Tanveer Shaikh
Dammam,Saudi Arabia
Summary
An experienced individual with 23 years of experience in Biopharmaceutical and pharmaceutical industry, steering the production of sterile lyophilized and liquid vials & ampoules, I've embraced a Lean manufacturing philosophy that emphasizes efficiency and continuous improvement. Collaborating closely with cross-functional teams, have maintained an unwavering focus on process validation and qualification, contributing to the company's reputation for reliability and safety in the competitive pharmaceuticals field. Focused [Job Title] with impressive track record in collaborative, cross-functional teamwork within high-pressure environments. Adept at project planning and managing multiple accounts at once. Dedicated to improving company sales goals and meeting business objectives.
Overview
24
24
years of professional experience
5
5
years of post-secondary education
Work history
HEAD OF INJECTABLES DEPARTMENT
Klybeck Lifesciences SA
Dammam, Saudi Arabia
07.2024 - Current
- Ensure manufacturing operations at the facility to manufacture commercial parenteral in according to approved procedures/protocols, regulations, and schedules.
- Oversees validation/commissioning activities at the facility.
- Manage, supports, and participates in cGMP audits & GEMBA walkthrough of all production areas within the facility.
- Manage and mentor Production operations including but not limited to dispensing, formulation, Filling, inspection, packaging, and area recovery.
- Active participation to solving technical and managerial challenges of the plant in coordination with the concerned departments (engineering, maintenance, quality, warehouses, etc.).
- Ensure any non-conformity or deviations from the process, preset specifications and criteria are thoroughly and properly investigated including identifying and implementing effective CAPAs to prevent any re-occurrence.
- Manages key manufacturing metrics/site goals, supports critical program milestones, and drives continuous improvement.
- Ensures the effective use of material, equipment, and personnel in production quality product. Maximize utilization of headcount resources and control production to achieve profitability target.
- Achieving monthly production KPI’s and applying operational excellence to define and achieve revised KPI’s with proper utilization of resources and minimization of waste at different stages of manufacturing and packaging.
- Value stream mapping of newly transferred process to minimize production lead time.
- Participate in technology transfer from R&D to Production for the newly approved products. Identifies critical process parameters and critical quality attributes.
- Creation of change control for new product transfer and assigning impact assessment to all related sections. Follow up for closing change assessment and plan for implementation of applicable changes before transfer of product to production scale.
- Participate in preparation of risk assessments related to production and quality where production part is involved.
- Prepare root cause analysis report by applying investigation tools (e.g. Ishikawa, 5Why’s, Parato chart etc), for investigating any non-conformance.
- Plan and execute aseptic process simulation (Media fill) activities.
- Prepare and maintain departmental annual budget through CAPEX & OPEX.
Production Supervisor
Tabuk Pharmaceutical Manufacturing Company
Dammam, Saudi Arabia
06.2020 - 06.2024
- Responsible for supervising Aseptic department manufacturing and packaging activities.
- Plan, schedule, and coordinate departmental activities (including staffing) to fulfill sales orders, meet inventory requirements, and deliver manufactured products in accordance with established procedures and approved processes.
- Supervise and participate in the production operations.
- Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data
- Ensures proper manufacturing processes are followed in accordance to written documentation (i.e., Batch Records, cGMPs, SOP’s).
- Currently managing team of 24 persons for the manufacturing, filling and packaging of Injectable products which has sterile, terminally sterilized and lyophilized products.
- Maintaining the monthly KPI by fulfilling the monthly manufacturing requirements.
- Maintains and revises procedures associated with production processes to ensure accuracy, consistency and product quality.
- Create, edit, and maintain necessary documentation (SOP’s, Work Instructions).
- Investigates and eliminates departmental non-conformities in manufacturing processes by employing root cause analysis and implements corrective and preventative actions.
- Assist in developing plant layout in planning rearrangement of facilities, equipment and operations for better utilization of space and to increase capacities.
- Supports process validations by defining process to quality parameters, executing protocols, collecting/interpreting data and supporting protocol summary where needed.
- Trains, motivates, monitors and evaluates performance of manufacturing employees.
- Develop and implement departmental cross training initiatives to allow for flexible resources and aid in improved capacities.
- Actively participates with internal and/or customer audits.
- Ensure all manufacturing safety policies and procedures are implemented and maintained at all times.
- Works closely with internal departments to assure commitment to customer is met in a timely manner.
- Responsible for creating production master recipes and production versions in SAP.
- Prepare and maintain departmental annual budget through CAPEX & OPEX.
- Performs other duties as assigned.
- Currently handling Aseptic product portfolio of 58 products which comprise of different fill volumes in vials & ampoules.
- Responsible for executing performance trials for new primary and secondary packaging materials.
- Responsible for creating, executing and review of deviation, change control, CAPA etc.
IN-CHARGE QA PRODUCT RELEASE
SPIMACO
Buraidah, Saudi Arabia
02.2016 - 03.2020
- Approval and final release of the batches comprising of oral solid, oral liquid, semi solid, injectables to market as per supply chain priority.
- Final review of executed batch records in PAS-X (Manufacturing & Packaging).
- Review of pre and post execution of deviation, change control and CAPA and its impact assessment.
- Review of Master Batch Record (MBR), Generic Master Batch Record (GMBR) & Packaging Instruction (PI).
- Reviewing pre and post execution of validation documents that include process, product, and equipment qualification and cleaning validation.
- Review of Site Master File & Quality Manual.
- Developing Standard Operating Procedures (SOP) and Work Instruction (WI).
- Conducting internal audit within the organization.
- Preparation of Annual Product Quality Review (APQR).
- Review of Licensor Quality Agreement.
- Providing training in all aspects of Quality Management Systems and GMP including procedural updates.
- Preparation, execution and update of training record of colleagues in the department.
- Evaluation and assessment of customer complains.
- Review of Out Of Specification (OOS) and Out Of Trend (OOT) report.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Reduced the time of review of batch records by suggesting design improvement and providing more control in Master Batch Record in PAS-X.
- Key member in implementation of serialization project and optimized the serialization procedure (Track & Trace).
- Review of User Requirement Specification (URS).
- Responsible for annual budgeting of department.
- Preparation of monthly and annual report.
TEAM LEADER QA PRODUCT RELEASE
SPIMACO
Buraidah, Saudi Arabia
02.2015 - 01.2016
- Approval and final release of the batches during the delegation of In-Charge.
- Reviewing of executed batch records (Manufacturing & Packaging) of oral solid, oral liquid, semi solid and injectable products in PAS-X
- Collation of batch record as per certificate of release.
- Communication and follow up with different Production Dept. regarding review corrections and discrepancy (if any) in executed batch records.
- Preparation, review and updating of the departmental standard operating procedure and work instruction.
- Reviewing of Change Control and Deviation with respect to batch records.
- Responsible for recording the inputs of Annual Product Review.
- Responsible for updating the status of the reviewed batch in the SAP.
- Reviewing of the status of the batch in the SAP system and prioritizing the review of the batches as per the status.
TEAM LEADER QA ENVIRONMENTAL
SPIMACO
Buraidah, Saudi Arabia
02.2014 - 01.2015
- Monitoring of viable and non-viable particle count in Aseptic area (Injectables) and other manufacturing departments.
- Monitoring of viable count during each batch manufactured in Aseptic Dept.
- Annual and bi-annual monitoring of viable and non-viable particle count, air velocity and air direction monitoring of Aseptic area and all the laminar air flows in the plant.
- Annual and bi-annual monitoring of Autoclave validation.
- Conducting temperature monitoring of cold rooms in the plant.
- Preparation of qualification protocol for temperature mapping of cold room.
- Review of Performance Qualification protocols and reports on plant utilities like compressed air, purified water system, HVAC etc.
- Preparation and sterilization of media (e.g. SCDA) used for the viable monitoring.
- Preparation of settle plates (SP), SAS plates and contact plates (CP).
- Responsible for keeping the records of usage of SP, SAS and contact plates.
- Conducting weekly monitoring of purified water, water for injection (WFI) and steam condensate of all the user points in the plant.
- Preparation of trend for viable count monitoring of Aseptic area as well as other manufacturing area.
- Preparation of environmental monitoring report (viable and non-viable particle count, finger dabbing) of each Aseptic batch.
- Conducting Antibiotic containment test for testing traces of Penicillin in non-penicillin area and area surrounding the penicillin antibiotic department.
VALIDATION OFFICER
SPIMACO
Buraidah
02.2010 - 01.2014
- Interface with staff in Operations, Technical Services, Project Engineering, Quality Control & Compliance and Quality Assurance to coordinate resources and complete validation activities in timely manner.
- Review and approval of new and updated Manufacturing process specification (BMR) & Packaging Instruction (BPR) of all dosage forms.
- Develop and execute validation protocols for the manufacturing processes, packing processes, cleaning processes, hold time validation activities of all pharmaceutical dosage forms.
- Develop and execute Performance Qualification (PQ) activities of Mfg. & Pkg. process related equipments.
- Assessing and evaluating the deviation and change control rose ensuring that the validated status of plant and equipment is not compromised.
- Follow up and review of the executed validation/ revalidation/ verification activities, protocols, validation data and preparation of Validation Report.
- Timely submission of executed validation documents along with Validation Report to QA for the final issuance of Validation certificate.
- Maintaining the validation status of every Department, coordination with Development & Production Planning Department in advance for the new product/ processes that needs to be validated.
- Preparing the Validation Maintenance Review report on periodic basis to evaluate and confirm the validated status of respective process and further issuing the Validation certificate for assuring the validated status of the process till next review unless and until no change in the equipment, manufacturing process, active ingredients, cleaning process etc.
- Reviewing and assessing the Manufacturing process scale up reports, Manufacturing Process Specification (MPS), Departmental cleaning processes, Packing P.I. sheets and batch documents.
- Author, review & prepare (when required) Validation Department SOP’s.
- Participate in external and internal GMP audits and provide audit responses for audit observations.
- Assist in corrective and preventive action (CAPA) and Deviation programs.
- Review the routine monitoring data related to room monitoring & purified water system.
- File and scan executed validation protocols in the validation archive system.
- Prepare validation strategies and validation implementation plans.
- Support FDA, Licensor & Customer audits as required (with participation, retrieving data and documentation)
- Preparing the validation department budget.
- Conducting the weekly planning of departmental activities, capturing minutes of meeting and publishing the same as an assignment to Department persons.
- Preparing the monthly report for the validation department.
- Draft, review and prepare the “Departmental Continuous Improvement Program “to increase the knowledge and expertise of the Department personnel
SENIOR BIOUPSTREAM SPECIALIST
SPIMACO
Buraidah, Saudi Arabia
10.2004 - 01.2010
- Preparation of large-scale media and buffers for the manufacturing of recombinant protein.
- Looking after adherent cell culture process from roller bottles till bioreactor stage.
- Looking after mammalian cell culture bioreactor process.
- Assembling and sterilization of bioreactors.
- Microfiltration of harvest for further processing in purification section.
- Assign the activities and maintaining the shift plan for the Upstream Section.
- Responsible for the preparation and review of the Manufacturing Process Specification (MPS).
- Responsible for the preparation and review of Departmental SOP’s and Work Instruction.
- Responsible for raising the departmental change control and deviation (if any).
- Responsible for participating, reviewing and answering the internal audit of the department.
- Maintaining the records of inventory and non-inventory items in the department.
- Responsible for raising the purchase order requisition for the non-inventory items and it's follow up.
- Responsible for the maintenance of the in-process Nova Bioanalyzer for the testing of glucose, lactate, ammonia, CO2, Dissolved oxygen (DO) etc.
- Participate in departmental budget preparation and project scheduling.
- Oversee/execute selected studies and protocols for processes and systems.
R&D OFFICER, BIOPHARMA DEPARTMENT
Wockhardt Ltd.
Aurangabad, India
06.2001 - 09.2004
- Development of mammalian cell culture process (Adherent as well as suspension) for the large scale manufacturing of recombinant protein.
- Handled different cell lines like CHO cells, BHK21 cells.
- Planning and execution of fermentation studies for improving the yield of recombinant protein.
- Handling media preparation, buffer preparation and sterilization by filtration.
- Handling Bioreactors from different manufacturers like Sartorius, Bioengineering, New Brunswick etc.
- Participating with senior scientists in planning the new experiments for developing the manufacturing process.
- Handling cleaning in place (CIP) & sterilization in process (SIP) of Bioreactors.
- Capturing and documenting the critical process parameters, corresponding yield and purity of protein of interest.
- Responsible for development as well as scale up runs.
- Preparation of Batch manufacturing record and departmental SOP’s.
- Preparation of Development as well as scale up report.
- Successfully scaled up and transferred the manufacturing process of producing recombinant protein to production level.
Education
Master of Science - Microbiology
Government Institute of Science
Aurangabad / India 06.1999 - 05.2001
Bachelor of Science - Microbiology, Chemistry & Botany
Swami Ramanand Teerth Marathwada University
Nanded / India 06.1996 - 05.1999
Skills
- Technology transfer Pharma injectables & Biosimilor API manufacturing
- Lean Six Sigma Green belt and Black Belt Certification in progress from EduHab UAE
- SAP4 HANA
- Electronic batch record (BMR & BPR) - Werum MES-PAS-X
- eQMS system (Trackwise)
- Windows Office (Excel, power point & word)
- GEMBA Walk
- OEE
Languages
English
Fluent
Urdu
Native
Hindi
Native
Marathi
Native
Accomplishments
Best Employee award at SPIMACO.
Best employee award at Tabuk Pharmaceutical Manufacturing Company.
References
References available upon request.
Timeline
HEAD OF INJECTABLES DEPARTMENT
Klybeck Lifesciences SA
07.2024 - Current
Production Supervisor
Tabuk Pharmaceutical Manufacturing Company
06.2020 - 06.2024
IN-CHARGE QA PRODUCT RELEASE
SPIMACO
02.2016 - 03.2020
TEAM LEADER QA PRODUCT RELEASE
SPIMACO
02.2015 - 01.2016
TEAM LEADER QA ENVIRONMENTAL
SPIMACO
02.2014 - 01.2015
VALIDATION OFFICER
SPIMACO
02.2010 - 01.2014
SENIOR BIOUPSTREAM SPECIALIST
SPIMACO
10.2004 - 01.2010
R&D OFFICER, BIOPHARMA DEPARTMENT
Wockhardt Ltd.
06.2001 - 09.2004
Master of Science - Microbiology
Government Institute of Science
06.1999 - 05.2001
Bachelor of Science - Microbiology, Chemistry & Botany
Swami Ramanand Teerth Marathwada University
06.1996 - 05.1999
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