Job Description
About the Organisation
We are a non-sterile formulations manufacturer operating across OTC and cosmetic 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.
Ready to Apply?
Don't miss this opportunity! Apply now and join our team.
Job Details
Posted Date:
March 1, 2026
Job Type:
Manufacturing
Location:
India
Company:
Umendra Life Sciences Pvt. Ltd.
Ready to Apply?
Don't miss this opportunity! Apply now and join our team.