Assistant Manager

Job Title Assistant Manager - 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