Designation | Head ( DGM) - QA - Liva Pharmaceutical, Zydus, Injectable, Vadodara - 1 Opening(s) |
Job Description |
- To head Quality Assurance of formulation Injectable manufacturing facility.
- To approve the Standard Operating Procedures pertaining to manufacturing and control of drug products.
- To approve master production and packing records.
- To approve specifications, sampling instructions, test methods and other quality control procedures.
- To ensure that internal audit (Self-inspection) are performed and compliance is ensured.
- To approve changes in the manufacturing process, specifications, testing procedures, systems, operations, facility, documents etc.
- To ensure that appropriate initial and continuing training of SOPs and other cGMP topics is carried out.
- To ensure that all the necessary in process quality assurance activities are carried out.
- To ensure compliance of cGMP in the manufacturing, packing and release of drug products.
- To ensure that appropriate validations are done.
- To review and approve validation protocols and reports.
- To ensure that effective system are used for maintain and calibrating critical instruments.
- To ensure that effective system is in place for maintenance of equipment.
- To approve qualification protocols and reports.
- To ensure review of completed Batch Manufacturing Records for critical process steps before release.
- To ensure that quality related complaints are investigated and resolved.
- To ensure that product failures are investigated and resolved.
- To ensure vendor evaluation/audits of Raw & Packing Material suppliers.
- To approve art works.
- To ensure that product sampling is performed as per Standard Operating Procedures.
- To ensure that deviations are investigated appropriately and CAPA is implemented.
- To ensure product quality reviews are performed at regular intervals.
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Desired Profile |
- Hands-on expertise of handling Quality Assurance function at large scale Formulation (Injectable) Pharma manufacturing facility in an environment of increasing regulatory complexity.
- Exposure of Lyophilisation
- Exposure of setting new labs with proper documentation and as per GLP standards.
- Should have worked in Senior Management level heading Quality Assurance function in regulated plants having approvals of US FDA, MHRA. etc.
- Should carry rich experience of IPQA, QMS, Method Validation, Method Transfer, Documentation, in large scale Formulation Pharma manufacturing facility.
- Hands-on experience in successfully handling and implementing cGMP (Current Good Manufacturing Practice) in Quality Assurance across different layers of the site.
- Must have an established track record of successfully facing Regulatory audits.
- Working closely with Quality & Regulatory functions to create a highly compliant environment.
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Experience | 15 - 20 Years |
Industry Type | Pharma / Biotech / Clinical Research |
Role | Other |
Functional Area | Other |
Education | UG - B.Pharma - Pharmacy
PG - M.Sc - Chemistry, M.Pharma - Pharmacy
Doctorate - Doctorate Not Required |
Compensation: | 25,00,000 - 30,00,000 P.A |
Location | Vadodara/Baroda |
Keywords | Injectable sterile QA Quality Assurance IPQA Validation Method Validation QMS |
Contact | Ruchir Someshwar Cadila Healthcare Limited |
Telephone | 7600030668 |
Email | ruchirsomeshwar@zyduscadila.com |
Job Posted | 2016-02-27 13:18:20.0 |
Reference | LPL-HLL/QA-Head/020 |
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