QA Executive
- K K Placement Services
- 1 to 5 Yrs
- Vapi, Silvassa, Daman
- 5 years ago
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Job Description
Issuance of Batch Manufacturing records and Batch Packing Records as per the production
planning.
Complete maintenance of control documents like specifications, method of analysis, batch
manufacturing records, equipment cleaning records, Validation master plan, site master file
etc
To complete and send the customer questionnaires along with all required supporting.
To qualify raw and packing material vendors as per SOP and prepare Approved vendor
list.
Review of Batch Manufacturing Records, Batch packing records and equipment cleaning
records and test protocol.
Preparation of standard operating procedures.
Handling of market complaints, change control, deviations, out of specifications and out of
trend.
Involve in investigation of deviation and out of specifications and out of trend.
Daily plant round to ensure online GMP compliance with respect to SOPs and Operations.
To monitor the stability program and evaluate the stability study data.
Send sample and COA as per customer requirement.
To support regulatory department by sending required documents and/or records.
To prepare and review the protocols for equipment qualification and process validation and
execute the same in coordination with concerned team members.
To plan and coordinate the internal quality audit as per the schedule. To keep the tracking
record of each non conformance raised during audit and its follow up for closures.
Responsible for document control and records retention.
To review the Specifications and test procedures and get it approved.
Monitoring dispatch related activities and documentation for the same.
Perform the vendor evaluations with coordination of Purchase, PD Lab and QC
Filled vendor Questionnaire received from outside party.
Prepare documents for ISO audit.
Review Analytical Method Validation protocol and report.
Review software challenge protocol and report.
Prepare Quality risk assessment document.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Quality (QA-QC)
Functional Area: Not Applicable
Role/Responsibilies: QA Executive
Contact Details:
Company: K K Placement ServicesLocation(s): Vapi, Silvassa, Daman
K K Placement Services
K.K. Placement Services Shop no.34, Chamunda Dream City. Beside St.Xavier high school. Koparli Road, Chharwada, Vapi- 396 191
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