Head Quality Control (OSD Facility)
Acme Generics LLP
Full time- 10+ years
- Not Disclosed
- Baddi, India
- Post Date: Feb 21, 2024
- End Date: Apr 21, 2024
- 10+ years
- Not Disclosed
- Baddi, India
- Post Date:Feb 21, 2024
- End Date: Apr 21, 2024
Skills:
- Quality control
- Operations
- Inspection
Job Description:
Responsibilities
- To manage QMS activity like change control, Deviation, CAPA, OOS, OOT, Lab events etc.
- To Conduct Risk Assessment& SOP reviews; investigating& supporting in the grievances.
- Responsible for Document & review Specification, SOPs, Review of Test Data Sheet, Analytical Test Report & Masters.
- Responsible for review of Method Validation Protocols & Method Validation Reports.
- To Monitor the Review of calibration/Preventive maintenance schedule.
- Responsibilities to Initiate for Procurement of impurity standard/reference standard, chemicals/reagents, columns, Laboratory glasswares etc.
- To Develop and implement Site Policies & Procedures (SOPs) to assure compliance with regulatory requirements, and corporate policies
- Responsibilities to Supervising deviation review and managing the CAPA review, approval and implementation reviews
- To Create goals, objectives and measures to drive continuous improvement of the QC operations
- Responsible for implementing the CAPA Parameters after investigation.
- Responsibilities assign to check the effectiveness of CAPA.
- To ensure Co-ordination for IQ, OQ, PQ and qualification plan of the instruments.
- Responsible for Coordinate & present all relevant documents to external auditors and to ensure that corrective measures are taken on any non-compliance finding.
- To Review method transfer protocols & reports & stability protocols.
- Responsible for rendering technical support to the Section in charges and managers.
- To Review various submissions to General Export and other regulatory markets related to quality control.
- Responsible for Review of comparison protocol & report of multimedia DRP & Dose dumping between RLD & exhibit batches.
- To complete quality projects within time by proper planning & execution of planning.
- To ensure the Implementation of several measures to identify deformities, malfunctions or other abnormalities such as Periodic verification of instruments/Equipment / components / products, Trending of failures.
- To Coordinate with various cross functional groups for timely availability of API/RM, PM , manufacturing area (Production), Analytical documents (Like Method Transfer, Specifications, Analytical Testing procedures etc.) & Quality control facility (Like column, critical chemicals working standard & impurities).
Qualification & Experience
- M.sc B. pharma, M. pharma
- Experience: 16-20 Years
Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years of Experience"
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Salary
Not Disclosed
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Role
Head of Department
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Area of Practice
- Quality Assurance/ Quality Control
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Experience
10+ years
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