Senior Executive - Quality Compliance

Zentiva; Ankleshwar; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Zentiva is seeking a Sr. Executive - Quality Compliance (Supplier Quality Assurance) in Ankleshwar. You will lead supplier qualification, audits, and continuous quality improvement across third-party manufacturers, ensuring GMP and regulatory standards are met.

The role requires coordinating with procurement, R&D, manufacturing, and regulatory affairs to resolve supplier issues, maintain documentation, and drive risk-based quality programs in a fast-paced pharmaceutical environment.

Qualifications

• Bachelor or Master degree in Pharmacy, Chemistry, Biotechnology or related field is required.
• 6–8 years in Quality Assurance/Compliance in pharma, with at least 2 years in Supplier Quality Assurance.
• Exposure to regulatory inspections (e.g., USFDA, EMA, WHO) and global supplier management is preferred.

Responsibilities

• Lead and manage supplier quality assurance activities to ensure regulatory compliance and GMP adherence across suppliers and contract manufacturers.
• Plan, conduct and close supplier audits (on-site and remote); assess findings and drive CAPA closures.
• Draft, negotiate, and maintain Quality Agreements; review CoAs, stability data, and regulatory filings for compliance.

Skills

cGMP knowledge

Auditing

Documentation & compliance

Communication & negotiation

Analytical skills

Education

B.Pharm / M.Pharm / M.Sc

Tools

SAP ERP

QMS software

MS Office

Job description

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.

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.