Cipla - Deputy Manager - Audit & Compliance
- Cipla
- 8 - 13 years
- Mumbai
- 7 months ago
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Job Description
JD:
Skills:
- Candidate should be B. Pharm or M. Pharm with 10 -12 years of experience in Nonsterile dosage form like Solid orals, Liquid orals and External Preparations.
- Should have shop floor as well as QA experience.
- Should have strong regulatory knowledge of USFDA, EUGMP, TGA guidelines and work experience of regulated sites.
- Candidate should have experience of audits of formulations sites.
Responsibilities:
1) To prepare/review audit planner as per SOP in Trackwise as per requirement and planning of audits as per prepared schedule for existing/New proposed contract manufacturing sites and Depots.2) To perform roles of Initiator/Reviewer/Auditor/HOD as and when required in Trackwise External audit management.3) To prepare & provide audit agenda to the auditors and Contract manufacturing sites.4) To provide all details of the Contract manufacturing sites (site master file, pre-audit questionnaire in case of due diligence audit, previous pending CAPA in case of periodic audit) to the auditors.5) Follow up with auditee/concerned person for audit compliance report & to ensure that audit compliance report is received from the unit within standard time.6) To review audit report & its compliance for approval and continuation for Cipla products. To send post review comments to location on inadequate compliance for timely closure of observations.7) Logging of all critical, major and minor observations as per SOP in Trackwise and follow up for their closure as per the target timelines provided by location.8) To escalate the audit compliance related issues like inadequate CAPA, overdue CAPA, disagreement of the location for compliance etc. to the reporting manager for further action.9) To provide technical assistance to the location for closure of audit observations, wherever required.10) To initiate and track site approval note for completion of approval from different departments after getting satisfactory compliance from audited site.11) To initiate and track the site exit activity for completion of discontinuation process from different departments for closed Contract manufacturing locations.
12) To prepare CAPA closure status for presentation in monthly PD.13) To perform the quality audit of existing/New proposed Contract Manufacturing sites and Depots.14) Internal and external auditor qualification as per SOP.15) Follow up with lead auditor for audit report of audited Contract Manufacturing sites and Depots.16) Harmonization of audit process for contract manufacturing sites across the globe.17) Review and sending the audit report to Contract Manufacturing sites and Depots.18) To perform the Risk assessment of Contract Manufacturing sites.19) To handle Trackwise Software for deviation activities as and when required.20) To handle Trackwise Software for raising Change request as and when required.21) Training completion in LMS software assigned by trainer.22) Handling of Trackwise for External Audit management.23) To use emSigner for electronic signature.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: CiplaLocation(s): Mumbai
Keyskills: audit compliance validation CAPA qualification sterile non-sterile media fill
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