Senior Executive - Quality Compliance

Zentiva Poland; Ankleshwar; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Zentiva Poland in Ankleshwar, India, seeks a Sr. Executive - Quality Compliance to lead supplier QA activities, ensuring GMP, regulatory alignment, and robust supplier qualification programs. You will oversee audits, CAPA closures, and Quality Agreements while coordinating with cross-functional teams to mitigate risks.

The role emphasizes risk-based supplier assessments, data integrity, and proactive quality improvements across the supply chain.

Qualifications

• B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
• Minimum 6–8 years of experience in QA/Quality Compliance in pharma, with ≥2 years in SQA.
• Exposure to regulatory inspections (USFDA, MHRA, TGA) and with global suppliers.

Responsibilities

• Lead and manage supplier QA activities ensuring GMP compliance across suppliers.
• Plan, conduct, and follow up supplier audits (on-site and remote).
• Evaluate audit findings, close CAPAs with suppliers, and track KPIs.
• Draft, negotiate, and maintain Quality Agreements with suppliers.
• Review CoAs, stability data, and regulatory filings for compliance.
• Support regulatory inspections with supplier-related documentation.
• Collaborate with Procurement, R&D, Manufacturing, and Regulatory Affairs to resolve supplier issues and drive improvements.

Skills

cGMP knowledge

Supplier audits

Regulatory compliance

Documentation

Communication & negotiation

Education

B.Pharm / M.Pharm / M.Sc in Chemistry or related field

Tools

MS Office

Electronic QMS

SAP ERP systems

Job description

Job Title: Sr. Executive - Quality Compliance (Supplier Quality Assurance)Department: Quality ComplianceReports to: Quality Compliance ManagerLocation: AnkleshwarPosition Type: Full-timeQualifications 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 filesQuality 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.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.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.