QA Officer in Ahmedabad, भारत

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.

 

Job Requirements: Vendor Qualification, cGMP, GLP, customer complaints investigation, CAPA System, equipment qualifications, Change Control, deviation closure, equipment cleaning records management, equipment use records management, Annual Product Quality Review, Process Validation records management, batch production records review, laboratory control records review, specification compliance, master production instructions compliance, SOPs compliance, purified water validation, documentation system management, document preparation, document review, document approval, document distribution, document issuance control, document revision control, revision history maintenance, production batch record approval, production deviation reporting, deviation evaluation, deviation investigation, calibration management, validation protocol review, validation report review, change evaluation, facility qualification, equipment qualification, audit exposure, Regulatory Audits, Customer Audits, State FDA Audits, USFDA Audits, internal audits, quality review of APIs, critical in-process control review, critical API test result review, batch failure review, critical deviation review, non-conformance review, investigation of deviations, process change review, analytical methods change review, holding time study review, stability study review, quality related returns review, complaint review, recall review