Manager- SME- QC Remediation Team

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10 – 15 Years



Job Description

Role: SME- Quality Control
Position: Manager
No. of positions: 1
Location: Visakhapatnam
Reporting to : Head-CTO/FTO Remediation

Key Responsibilities:

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

Personal Attributes:
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.

Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Other


Desired Profile

Education:UG -B.Pharma – Pharmacy, Any Graduate – Any Specialization
PG – M.Pharma – Pharmacy, M.Sc – Any Specialization, Any Postgraduate
Doctorate – Doctorate Not Required

Company Profile

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to:
Contact Details

Recruiter Name:Sukanya

Contact Company:Dr Reddys Laboratories Ltd

Telephone:Not Mentioned


Source by naukri…