Officer/Executive - QA (V)

Quality HR Services

2 - 5 years

3 - 5 Lacs

vapi

Posted:3 weeks ago| Platform:

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Skills Required

change control process validation quality assurance qms apqr chemistry capa equipment qualification quality control bpr bmr ipqa documentation customer audits cgmp oos computer skills product quality oot sop cleaning validation bpr review

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

To impart the departmental training & co-ordinate for cGMP training as per planned schedule.
To Coordination of Regulatory/Customer audit and its compliance. Review the audit feedback and provide the action plan for compliance of audit observation/ findings.
To perform self-inspection for all respective departments & evaluate the compliance of any reported non-compliance in the self-inspection report.
To review the deviation, change control, incident for impact on product quality and safety in QAMS.
Perform risk assessment for risk reduction/mitigation at acceptance label for product & QMS related documents as part of impact assessment.
Review of QA documents, review of specification & STP and other department procedure in DMS.
To review validation and qualification related protocol and monitor validation activity during the execution for review of validation report and ensure that validation should be executed as per VMP.
To review and update site master file, quality manual, validation master plan as per changes made in equipment, facility, policy and procedures there in.
To Prepare Annual Quality Review (APQR). Product
Review of Process validation and Equipment qualification protocol and report.

Required Skills

Must be excellent in written and spoken English; net savvy and adept at computer skills.
Logical thinking.
Organizing.
Good in communication.

Required Qualification: - B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

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