Role & responsibilities

Purpose To oversee and maintain strict analytical quality assurance and laboratory compliance in accordance with cGMP norms at the Ambernath facility. This role ensures the absolute integrity of analytical data, reviews laboratory validations, governs QMS records, and independently leads the section to support batch release activities.

Responsibilities

- Conduct comprehensive analytical document reviews, including raw worksheets, chromatograms, and Analytical Method Transfers/Validations (AMT/AMV).
- Review and approve Certificates of Analysis (CoA) from the QC lab for Finished Products, Raw Materials, and Packing Materials to facilitate batch releases.
- Lead the review of electronic audit trails and enforce strict computer system validation (CSV) protocols across lab software.
- Manage laboratory QMS records by handling OOS, OOT, CAPAs, Change Controls, and Deviations, while generating routine quality trend reports.
- Review laboratory support frameworks including column management, reference/working standard handling, and retention sample workflows.
- Oversee stability chamber management, including the rigorous review of stability protocols and product summary sheets.
- Review and verify equipment calibration data, instrument qualifications, and glassware cleaning validation protocols.
- Perform regular laboratory compliance walkthroughs and internal audits to maintain a continuous state of audit readiness.
- Review analyst qualification data to ensure all laboratory personnel are thoroughly trained and compliant before executing tests.
- Draft, review, and update technical laboratory documentation, including material specifications and Standard Testing Procedures (STPs).
- Lead the analytical QA group independently in the absence of the Manager,



handling daily planning and task distribution.
- Coordinate cross-functionally with QC, Manufacturing, Engineering, and Warehouse teams to streamline compliance timelines and resolve quality events.

Required Skills

- Instrumentation Compliance: Deep regulatory knowledge of handling and reviewing data from HPLC, GC, and Karl Fischer (KF), with exposure to FT-NIR and LC/MS considered an advantage.
- Audit Trail & CSV Review: Robust technical proficiency in reviewing electronic audit trails and ensuring 21 CFR Part 11 computer system compliance.
- QMS & Investigation Mastery: Proficient in evaluating complex laboratory investigations, identifying true root causes, and tracking the efficacy of CAPAs.
- Regulatory Knowledge: Sound understanding of global regulatory guidelines established by bodies such as the USFDA, MHRA, and TGA.
- Team Leadership & Planning: Excellent cross-functional coordination and workload planning capabilities required to manage an analytical QA section independently.

Preferred Candidate Details

- Education & Experience: Regular B.Pharm / M.Pharm or M.Sc degree with approx. 12 years of core experience in pharmaceutical Analytical Lab Quality Assurance (ALQA).
- Dosage Form Expertise: Extensive, direct exposure handling quality systems for OSD and Liquid Orals / Nasal formulations, with Injectables experience highly preferred.
- Audit Defense Exposure: Proven history of actively preparing for and defending laboratory data integrity during major regulatory audits (USFDA/MHRA).
- Operational Flexibility: Total readiness to work flexibly across all rotational shifts at the Ambernath site based on operational requirements.
- Travel Readiness: Willingness and adaptability to travel to other manufacturing site locations on an as-needed basis as per company policy.

📌 Assistant Manager - Analytical Quality Assurance (Formulation) (Mumbai)
🏢 Rubicon Research
📍 Mumbai