zentiva
Website:
zentiva.com
Job details:
Job Title: Sr. Executive
- Quality Compliance (Supplier Quality Assurance)
Department: Quality Compliance
Reports to: Quality Compliance Manager
Location: Ankleshwar
Position Type: Full-time
Qualifications And Experience
- Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
- Experience: Minimum 6–8 years of experience in Quality Assurance / Quality Compliance within the pharmaceutical industry, with at least 2 years in a Supplier Quality Assurance role.
- Preferred: Exposure to regulatory inspections (e.g., USFDA, MHRA, TGA), and experience in working with global suppliers.
Job Purpose
To lead and manage Supplier Quality Assurance (SQA) activities ensuring all third-party suppliers, vendors, and contract manufacturers comply with applicable regulatory requirements, company quality standards, and Good Manufacturing Practices (GMP). The role involves oversight of supplier qualification, audits, risk assessment, and continuous quality improvement initiatives within the pharmaceutical supply chain.
Key Responsibilities
Supplier Quality Management:
- Develop, implement, and maintain a robust supplier quality assurance system aligned with cGMP and regulatory requirements (e.g., USFDA, EMA, WHO).
- Lead supplier qualification, requalification, and performance monitoring programs.
- Conduct risk-based assessments and ensure supplier categorization based on product and service criticality.
Auditing & Compliance
- Plan, conduct, and follow up on supplier audits (on-site and remote) for API, excipient, packaging, and service providers.
- Evaluate audit findings, identify gaps, and oversee closure of CAPAs with suppliers.
- Maintain audit schedules, records, and ensure timely reporting.
- Maintenance of Approved Supplier List / GMP documents / Supplier files
Quality Agreements & Documentation
- Coordinate the drafting, negotiation, and maintenance of Quality Agreements with suppliers.
- Review supplier documentation such as CoAs, TSE/BSE statements, stability data, and regulatory filings for compliance.
- Ensure all supplier documentation is up to date and archived as per data integrity principles.
Regulatory Support
- Support regulatory inspections and provide supplier-related documentation during audits.
- Monitor regulatory changes and ensure suppliers are aligned with evolving GMP expectations.
Cross-Functional Collaboration
- Work closely with Procurement, R&D, Manufacturing, and Regulatory Affairs to ensure supplier issues are identified, communicated, and resolved efficiently.
- Participate in cross-functional quality risk assessments and supplier development programs.
Continuous Improvement
- Drive quality improvement initiatives with suppliers to enhance performance and reduce quality-related risks.
- Track and report quality KPIs related to suppliers and initiate corrective actions when targets are not met.
Key Skills & Competencies
- Strong knowledge of cGMP, ICH Q7/Q10, WHO, and global regulatory requirements.
- Experience in conducting and managing supplier audits.
- Excellent communication and negotiation skills.
- Strong documentation and analytical skills.
- Proficiency in MS Office tools and electronic QMS ,SAP ERP systems.
- Ability to work independently and manage multiple priorities under tight timelines.
Key Performance Indicators (KPIs)
- % of on-time completion of supplier audits and qualification activities.
- % of CAPA closures within agreed timelines.
- Supplier non-conformance rate (trend analysis and reduction).
- Compliance score during internal and regulatory audits.
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