Assistant Manager - Analytical Quality Assurance (Formulation)

Rubicon Research; Mumbai, Ambernath; On-site; INR 2,500,000 - 4,300,000; Full time

Job summary

Rubicon Research in Ambernath, India, seeks an analytical QA lead to ensure cGMP compliant data integrity, review validations, and manage QMS records. The role independently heads the section to support batch release activities and maintains audit readiness.

You will coordinate with QC, Manufacturing, Engineering and Warehouse, review CoA, oversee CSV, instrument qualifications, OOS/OOT, CAPAs, and document control, while guiding training and staff development.

Qualifications

• B.Pharm / M.Pharm or MSc with ~12 years in pharmaceutical Analytical Lab QA.
• Proven ability to lead analytical QA sections and audit readiness.
• Experience with USFDA/MHRA/TGA regulations is preferred.

Responsibilities

• Conduct comprehensive analytical document reviews including raw worksheets, chromatograms, and AMT/AMV.
• Review and approve CoA for Finished Products, Raw Materials, and Packing Materials to facilitate batch releases.
• Lead the review of electronic audit trails and enforce CSV protocols across lab software.
• Manage laboratory QMS records handling OOS, OOT, CAPAs, Change Controls, Deviations and trend reports.
• Review laboratory support frameworks including column management, reference standards, and retention samples.
• Oversee stability chamber management and review stability protocols and product summary sheets.
• Review equipment calibration data, instrument qualifications, and glassware cleaning validation protocols.
• Perform internal audits to maintain audit readiness.
• Review analyst qualification data to ensure training and compliance.
• Draft and update STPs and material specifications.
• Lead analytical QA group in Manager's absence and coordinate cross-functionally with QC, Manufacturing, Engineering, and Warehouse.

Skills

Instrumentation Compliance

Audit Trail & CSV Review

QMS & Investigation Mastery

Regulatory Knowledge

Team Leadership & Planning

Education

B.Pharm / M.Pharm or MSc

Tools

HPLC

GC

KF

FT-NIR

LC-MS

Job description

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: Strong 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.