Deputy Manager - Quality Assurance (QMS) For API

• Responsible for leading the external audit & providing compliance on time.
• To review and approve all department's Standard Operating Procedure.
• To ensure for the compliance of all Standard Operating Procedures.
• Strategic Planning & Execution of Quality Management System.
• To ensure the compliance of Quality Management system as per the requirement.
• To review and approve the Site Manager File (SMF), Validation Master Plan (VMP) and Quality manual.
• Review & approval of Quality documents Master BPRs, Validation Protocols & Reports, APRs, CPV reports.
• As qualified auditor, performing internal audits.
• As Qualified site training coordinator, providing training to new and existing employees on SOPs, GMP guidelines i.e. ICH, Data integrity…etc.
• Responsible for the approval and release of the Batch.
• Responsible for self-inspection or internal audit and compliance.
• To review and approve all Validation and Qualification Protocols and Reports.
• To ensure the compliance of Vendor Audits and approval of Contract Laboratory.
• To impart training on different topics including cGMP and GDP etc.
• To coordinate during technology transfer of products to the sites.
• To ensure that products are manufactured as per approved procedure.
• Responsible for the investigation of the market complaints, Product recall & its compliances.
• Responsible for review, approval, implementation, and verification of Corrective Action and Preventive Action.
• To provide compliance reports of audits.
• To ensure the Qualification and Re-qualification of the Equipment, Facility and System
• Responsible for review and approval of Stability Protocol and report.
• To ensure work discipline in the department.
• Responsible for quality agreement and its compliance.

Requirements:

• Minimum of 10 years of experience in Quality Assurance in the API industry, with a focus on Quality Management Systems
• Strong knowledge of regulatory requirements, such as EDQM, USFDA, WHO and ICH guidelines.
• Experience leading and managing a team of Quality Assurance.
• Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues.
• Excellent communication and interpersonal skills, with the ability to interact effectively with cross-functional teams.
• Attention to detail and a commitment to quality.