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Bal Pharma
10 Bal Pharma Jobs
5-6 years
₹ 5 - 6L/yr
Udaipur
2 vacancies
Analytical Quality Assurance (AQA)- Sr. Executive
Bal Pharma
posted 5d ago
Fixed timing
Key skills for the job
Overall implementation of Quality System.
Approval of Quality Documents (SMF, VMP etc..,)
Approval of Standard Operating Procedures.
Approval of Drug Master Files.
Approval of Master Formula Records.
Approval of Master Batch Manufacturing Records / Blending and Packing Records.
Authorization of Raw Material / Packing Material / In process / Recovered Solvents / Intermediate / Final API specifications & MOAs.
Authorization of Reprocess / Rework procedures.
Releasing / Rejecting RM / Intermediates / API analyzed due to retest.
Releasing / Rejecting Intermediates
Releasing / Rejecting Final APIs.
Approval of the new vendor samples.
Approval of the Vendor Questionnaire
Conducting Vendor Audit
Approval of new vendor & Vendor Evaluation
Approval of the Approved Vendor List and Vendor Rating.
Approval / Rejection of Change controls.
Approval / Rejection of deviations.
Investigation of Out of Specification (OOS) for the Raw material / Packing Material / Intermediate / Final API.
Review & Authorization of PO Intimation form.
Compliance for calibration of all the equipments / instruments
To lead and approve the validation / qualification activities at the site. Review and approval of process validation, blending validation, cleaning validation, temperature mapping, equipment qualification & other validation protocols & reports.
Review and Authorization of the executed BMRs, BPRs, Reprocess / Rework BMRs & laboratory control records of critical process steps before release of the API for distribution.
Release / Dispatch of products manufactured
Authorization of Certificate of Analysis
To investigate and resolve Quality related complaints.
Authorization of Returned/ Recalled/ Rejected Goods
Review and approval of the corrective & preventive action reports.
To take lead during internal audit.
Ensuring internal quality / regulatory / customer audit being performed and compliance for the observation done by regulatory / customer.
Review and approval of Periodic Product Review Reports, General Annual Review Reports & Annual review reports.
Carrying out audits for external laboratories and service providers
Conducting and providing training for all the personnel.
Organizing for Management review meeting.
Review & approval of filled customer questionnaires.
Approval of Objectives of all the departments
Any other responsibility as and when delegated by Management.
Employment Type: Full Time, Permanent
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