10 – 15 Years
No. of positions: 1
Reporting to : Head-CTO/FTO Remediation
Assess the Quality Control and Microbiology laboratories to ensure lab testing is in compliance with protocols, and cGMP regulations
To provide laboratory oversight – Testing of the finished product / raw material and microbiology work groups to ensure that testing is executed in a compliant manner
Evaluate completeness of documentation and validation of analytical methods as per cGMP requirements.
Perform and Review of laboratory investigations to derive the root cause and CAPA
Review of protocols and reports such as method validation, method transfer, process validation and stability
To develop protocols for assessment of laboratory data for accuracy and completeness
To perform laboratory analytical instruments compliance assessment against 21 CFR part 11 requirements
To perform the verification of electronic data management related to quality control testings
To perform the sample management assessments Receipt of Samples, Log books, Consumption records, Traceability and Discarding procedures to determine the potential unauthorized use of samples.
To review electronic data generated during analytical testing (i.e. data storage controls, acquisition path, audit trails, sequence of activities) for determining the potential data integrity and reliability issues, and to develop the corrective actions for mitigation of discrepancies identified along with product impact assessment.
To evaluate the microbiological test practices against the current regulatory expectations and best industry practices
Addressal of the compliance issues through implementation of procedures and risk assessments along with robust action plans
Development of risk based and prioritized action plan for the issues discovered as part oversight and regulatory inspections.
To ensure that the laboratory testing of components, containers, in-process materials, packaging materials and drug product are performed using validated methods against scientifically-derived, fit-for-purpose specifications
Training to all laboratory employees on media Fills, Best microbiology practices, Aseptic Behaviour, Computerized Systems, Analytical instrument Qualification, Method validations, Chromatographic data (electronic) management etc.
To assess that the reduced or skip lot testings of incoming materials are justified.
Must have faced regulatory audits like EDQM, MHRA, USFDA etc. in a leading role
Should have worked in site QC in API and/or Drug product manufacturing
Education & Experience: Post graduate Above 10 Years of experience in Pharmaceutical Quality related to Sterile Dosages and Oral Solid Dosages
A strong communicator, with high energy and ability to influence and persuade others
Good problem solving skills
Flexible, adaptable and creative
Excellent interpersonal skills
Note- Not relevant to QC-Microbiology Background.
PG – M.Pharma – Pharmacy, M.Sc – Any Specialization, Any Postgraduate
Doctorate – Doctorate Not Required