QA Officer — Formulations Manufacturing | Bavla, Ahmedabad

About the Organisation

We are a non-sterile formulations manufacturer operating across solid dosage and liquid dosage segments, with manufacturing operations spanning dispensing, manufacturing, filling, and packing areas. Our facility near Bavla, Ahmedabad is in an active phase of strengthening its quality systems building documentation discipline, improving shop-floor QA oversight, and preparing for regulatory audits. This is a working facility with real accountability at every level of the QA function.

Role Purpose

The QA Officer will own day-to-day quality assurance activities on the shop floor and within the documentation system. The person in this role is expected to be present where decisions get made at the line, in the review room, and in the documentation system not just as a checkpoint, but as someone who understands why each control exists and ensures it functions.

This role is part of an expanding QA/IPQA team reporting to the QA Manager (HOD).

Key Responsibilities

IPQA and Shop Floor Oversight

• Execute in-process quality checks across manufacturing, filling, dispensing, and packing areas
• Perform and document line clearances at each stage of production
• Identify and escalate deviations in real time; support root cause investigation and CAPA closure
• Coordinate with production supervisors to ensure compliance without disrupting operational flow

BMR/BPR and Documentation

• Review and reconcile Batch Manufacturing Records and Batch Packaging Records for accuracy and completeness before batch disposition
• Ensure all entries conform to data integrity requirements; identify gaps and drive corrections at source

SOP and QMS Management

• Participate in drafting, reviewing, and revising SOPs aligned with current operations and regulatory expectations
• Maintain controlled document systems; track SOP issuance, obsolescence, and acknowledgement records
• Support implementation of QMS improvements as the facility upgrades its documentation infrastructure

Validation and Qualification Support

• Assist in process validation, cleaning validation, and equipment qualification activities (IQ/OQ/PQ)
• Maintain and update validation master documentation; coordinate with engineering and production teams during execution

Stability and Control Samples

• Coordinate placement and retrieval of stability samples per approved protocols
• Maintain control sample logs and ensure timely review and documentation of results

Audit Readiness

• Support preparation and mock audit activities for internal, customer, and regulatory audits
• Ensure area-level documentation, logbooks, and records are audit-ready at all times

Training Support

• Participate in GMP training execution for shop floor personnel
• Maintain training records and assist in identifying retraining needs based on deviation trends

What We Are Looking For

• 1 to 6 years of experience in QA or IPQA within a pharmaceutical formulations facility
• Hands-on familiarity with non-sterile dosage form manufacturing environments (solid, liquid, or semi-solid)
• Strong documentation discipline someone who understands that incomplete records are a quality failure, not a paperwork issue
• Working knowledge of Schedule M, WHO GMP, and QMS fundamentals
• Exposure to US FDA / CFR 21 Part 211 requirements is preferred; candidates without this exposure but with strong foundational QA practice are equally welcome
• Ability to work on the shop floor and engage directly with production and engineering teams
• B.Pharm / M.Pharm / M.Sc (Chemistry or related discipline)

Work Location and Structure

Bavla, near Ahmedabad, Gujarat. This is a full-time, on-site role at the manufacturing facility. Candidates who are based in or willing to relocate to the Ahmedabad region are encouraged to apply.

To Apply

Send your resume with a brief note on your current QA responsibilities and the product types or dosage forms you have worked with.