QA Officer Job Profile / Responsibilities • To ensure Vendor Qualification. • To ensure cGMP and GLP in production and Lab. • To investigate customer complaints if any. • To ensure the CAPA System. • To ensure equipment qualifications. • To ensure Change Control if any. • To check comment planned deviation if any. • Closure planned and unplanned deviation in time. • To check and ensure equipment cleaning records and equipment’s use records. • To ensure Annual Product Quality Review. • To ensure Process Validation records. • To ensure completed batch production and laboratory control records of critical process step before release of the FG Materials. • To ensure all specifications and master production instructions. • To ensure the SOPs. • To ensure water purified water validation. Work Profiles Documentation System • All documents related to the manufacturing of intermediate or APIs ensure prepare, review, approve and distribution according to written procedures. Documents can be in paper or electronic form. • The issuance, revision, superseding and withdrawal of all documents controlled with maintain of revision history. Production: • Approval all production batch records and ensuring that these are completed and singed.



• Ensure that all production deviation is reported and evaluated and that critical deviations are investigated and conclusions are recorded. • Ensure the necessary calibrations are performed and records perfectly. • Ensure that validation protocols and reports are reviewed and approved. • Evaluating proposed change in product, process or equipment’s and when appropriate, modified facilities and equipment are qualified. Quality : • Audit Exposure like Regulatory Audits / Customer / State FDA / USFDA • Verify compliance with the principles of cGMP for APIs, regular internal • Audits performed in accordance with an approved schedule. • Regular quality review of APIs conducted with the objective of verifying the Consistency of the process. Such review normally conduced and documented Annually. • Review of critical in-process control and critical API test result. • Review of all batches that fail to meet established specification. • Review of all critical deviations or non-conformance and related Investigation. • Review of any changes carried out to the process and analytical methods. • Review of results of holding time and stability study programs. • Review of all quality related returns, complaints and recalls.

📌 QA Officer (Ahmedabad)
🏢 Easebiz Fintech Solutions
📍 Ahmedabad