Saquib Shaikh
Jalna
Summary
Experienced professional with a strong work ethic and expertise in Quality Assurance and the microbiology department. With ~10 years of industry experience, currently serving as a Deputy Manager in Quality Assurance at Panacea Biotec Ltd. Committed to ensuring the highest standards of quality, brings a meticulous approach to work and a deep understanding of the intricacies of the field. Seeks opportunities to leverage skills and contribute to the success of a dynamic organization in need of a dedicated professional in Quality Assurance.
Overview
10
10
years of professional experience
5
5
Certificate
Work History
Deputy Manager, Quality Assurance
Panacea Biotec Ltd.
03.2021 - Current
- Day to day monitoring and ensuring compliance of vaccine development operations with applicable regulatory requirements, internal Quality standard and GLP.
- Ensure documentation (SOPs, Lab notebooks, operations logs, work instructions, records, Study designs) are up-to-date as per ALCOA Plus and accessible.
- Review of the technical documents like SOPs, Protocols, Reports, Product Development Report, Analytical Development Report, Cell bank & Virus details, Specifications, Information Modules etc.
- Review of stability design, Stability indicating Parameters, stability protocol and reports and monitoring the stability studies for Shelf life determination.
- Review and approval of Critical Process Parameters (CPP) & Critical Quality Attributes (CQA).
- Optimization & Consistency Batches protocol and Report review and monitoring critical steps.
- Conduct internal audits and coordinate external audits to ensure adherence to regulatory and organizational standards.
- Technology Transfer activities of developed product to the receiving site
- Conducting Gap assessment for process and equipment during Tech Transfer.
- Review and preparation of Technology Transfer package.
- Review, approval and timely closure of Quality Management System documents (Deviations, Change controls, Out of specifications, CAPA with risk assessments)
- Ensure implementation of CAPA and its effectiveness review
- Ensuring the readiness for Regulatory inspections and internal audits (Self inspections)
- To participate in project meetings and to ensure compliance with respect to action items and project mile stones
- To collaborate with cross functions to support company objectives.
- Coordination with Regulatory affairs for Dossier submission to Regulatory bodies and compliance of the Queries received(like form 29, CT 10, C3B etc)
- Imparting training as per training program and to the new joinee.
- Issuance, archival and retrieval of documents.
Officer, Quality Assurance
Emcure pharmaceutical Pvt ltd.
02.2019 - 06.2020
- Executed Batch Manufacturing Record (BMR), Batch Packing Record (BPR) Review
- In process of manufacturing operations
- Review of Production and QC documents for compliance
- Visual inspection of finished goods for AQL release
- Protocol & SOP Preparation
Jr. Executive QC Microbiology
Pfizer Healthcare Pvt Ltd.
10.2015 - 02.2019
- Microbiological testing's (MLT, BET, Sterility)
- Aseptic area monitoring
- Water sampling from production Area
- Method validation of microbiological testing's
- NVPC monitoring of production area
- Active participation in Process simulation
Junior Executive, QC Microbiology
Baxter India PVT LTD
04.2014 - 10.2015
- Microbiological testing's (MLT, BET, Sterility)
- Aseptic area monitoring
- Water sampling from production Area
- NVPC monitoring of production area
- Active participation in Process simulation
Education
M.Sc - Microbiology
Govt Institute of Science, Dr.B.A.M University
Aurangabad 2013
B.Sc - Microbiology
Dr. B.R Barwale College, Dr.B.A.M.University
Aurangabad 2011
H.S.C -
M.Azad College, Aurangabad Borad
2007
S.S.C -
A.I.U.H.S, Aurangabad Board
2005
Skills
- Quality oversight
- Technology Transfer
- Quality Management Systems (QMS)
- Documentation Review
- Audit management
- Compliance
- Change Control Management
- RCA and CAPA Management
- Risk management
- Microbiological testing verifications
- Qualification and Validation
- Media fill monitoring
- Leadership & Team Management
- Stakeholder communication
- Problem-Solving: Analytical thinking, decision-making under pressure, and risk mitigation
- Team Leadership
- Effective communication among CFT's
- Employee training
Languages
English
Hindi
Marathi
Urdu
Certification
- Technology Transfer Training Programme by joint Venture of DCVMN & Hilleman Lab Singapore, 27 may to 12 July 2024
- Certificate of Appreciation, by PBL, 2023
- Key Employee Award- Baxter India Pvt Ltd, 2014
- Certificate In Environmental Science programme, By Dr. B.A.M. University, 2010
- Certificate in Compulsory Computer Course by Dr.B.A.M University,2009
Timeline
Deputy Manager, Quality Assurance
Panacea Biotec Ltd.
03.2021 - Current
Officer, Quality Assurance
Emcure pharmaceutical Pvt ltd.
02.2019 - 06.2020
Jr. Executive QC Microbiology
Pfizer Healthcare Pvt Ltd.
10.2015 - 02.2019
Junior Executive, QC Microbiology
Baxter India PVT LTD
04.2014 - 10.2015
M.Sc - Microbiology
Govt Institute of Science, Dr.B.A.M University
B.Sc - Microbiology
Dr. B.R Barwale College, Dr.B.A.M.University
H.S.C -
M.Azad College, Aurangabad Borad
S.S.C -
A.I.U.H.S, Aurangabad Board
Personal Information
- Father's Name: Shaikh Adil
- Date of Birth: 03/19/90
- Nationality: Indian
- Marital Status: Married
Audits Faced
- USFDA in Pfizer Healthcare India and Emcure Pharmaceutical
- MHRA in Pfizer Healthcare India
- TGA in Emcure Pharmaceutical
- CDSCO in Baxter India and Panacea Biotec Ltd.
- Russia Audit in Panacea Biotec Ltd.
- Consultants Audit-Step Change & Lachman, PWC in Pfizer Healthcare India
Personal Information
- Father's Name: Shaikh Adil
- Date of Birth: 03/19/90
- Nationality: Indian
- Marital Status: Married
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