Quality Manager 3rd Party Manufacturing
Quality Manager 3rd Party Manufacturing
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Job Description
Department: Quality Assurance / Quality Control
The Quality Manager will be responsible for ensuring compliancequality control and regulatory adherence at thirdparty manufacturingfacilities. This role involves auditing and monitoring thirdpartymanufacturers ensuring GMP compliance product quality and regulatorystandards are met while working closely with production regulatory andsupply chain teams. The ideal candidate should have a strong productionbackground with expertise in quality assurance and control.
Key Responsibilities:
1. Quality Oversight of 3rd Party Manufacturers
- Monitor quality standards at thirdparty manufacturing facilities.
- Conduct regular site visits audits and inspections to ensure compliance with cGMP WHOGMP USFDA MHRA and other regulatory guidelines.
- Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs).
2. Compliance & Regulatory Audits
- Ensure thirdparty manufacturers adhere to quality agreements SOPs and regulatory requirements.
- Coordinate with regulatory teams for dossier submissions product registrations and regulatory inspections.
- Manage deviations OOS (Out of Specification) OOT (Out of Trend) and CAPA (Corrective and Preventive Actions) at thirdparty sites.
3. Quality Control & Product Testing
- Ensure raw material inprocess and finished product testing is conducted as per standard specifications.
- Review stability studies analytical data and lab investigation reports.
- Collaborate with analytical labs and QC teams to ensure product quality compliance.
4. Vendor Qualification & Process Validation
- Conduct vendor qualification supplier audits and performance evaluations.
- Review and approve process validation cleaning validation and analytical method validation reports.
- Work with thirdparty manufacturers to optimize processes and improve product quality.
5. Documentation & Reporting
- Maintain quality agreements technical agreements and audit reports for thirdparty sites.
- Ensure all documentation aligns with GMP ICH and other regulatory guidelines.
- Prepare monthly quality reports noncompliance reports and corrective action plans.
6. CrossFunctional Collaboration
- Coordinate with production supply chain regulatory and R&D teams to ensure smooth manufacturing operations.
- Providetraining to thirdparty manufacturers on quality standards GMP complianceand best practices.
Requirements
Key Requirements:
- Education: B.Pharm / M.Pharm
- Experience: 812 years in pharmaceutical production & quality management with at least 35 years in thirdparty quality oversight.
- Technical Skills:
- Strong knowledge of GMP ICH guidelines USFDA MHRA and WHOGMP compliance.
- Experience in quality audits regulatory inspections and vendor qualification.
- Proficiency in process validation analytical testing and stability studies.
- Handsonexperience with ERP systems (SAP TrackWise or similar) and Excelfor reporting.
Required Experience:
Manager
Employment Type
Full-Time
