Purpose of the Role: - Implementing a Quality Management System (QMS) at Biopharma - Build quality awareness at local management and ensure that local management fulfils its role with regard to quality requirements as defined in the applicable regulations. - Reporting quality performance indicators to local management and take leadership in the performance of Tier 1 Quality Councils and Quality Management Reviews. - Establishing and managing an appropriate Quality Department that covers all GMP/GDP quality critical task. - Implementing Corporate and Global company standards and procedures, international and local applicable GDP regulations - Ensure that the defined quality systems and standards are implemented and followed so that the high quality standards of company are achieved. - Releasing products for the local market. - Manage quality related aspects of company GMP/GDP vendors and partners in the country. - Liaise with quality global functions (MS-Q) and report status of quality systems implementation, KPI and quality issues Responsibilities: Accountable for the quality and GMP/GDP compliance of: - QA activities and quality systems in place, and its maintenance - Local quality management system - Release of product on the market - Quality of products put on the market - Preparing and coordinating health authority inspections - Training of local personnel on locally implemented quality systems and GMP/GDP matters (training program, training record) - Coordinating product recalls and withdrawal of the local country including investigational medicinal product (IMP) and marketed medicinal products - Handling of GMP/GDP deviations (including receiving, recording, investigating and closing out) - Changes control management for GMP/GDP activities - Handling and escalation of complaints received from customers (including receiving, recording, investigating and closing out) - Implementation and management of quality documents - Create internal and external audit plan, program and audit execution by qualified auditors - Relationship with local health authorities in partnership with local Regulatory Affairs - Assuring GMP/GDP critical vendors are qualified (maintaining a vendor list, establishing Technical Agreements with the vendors, assuring vendor are regularly monitored I followed up) - Provide support and monitor quality issues to resolution within the organization and external suppliers. - Where applicable, to capture, record and forward the information to the Local Patient Safety Person (LPS) - Packaging materials: review and approval as QA representative - Review and approval of quality documents - Assuring corrective and preventive actions are timely defined, documented, tracked and closed in order to improve continuously the quality of the quality processes - Assuring Quality critical changes are documented according to a formal Change Control process and that the appropriate actions are taken before implementing the changes - Releasing products delivered to the subsidiary and assure the products are manufactured in line with the Marketing Authorization - Act as a MBQ coordinator, as per the specific MBQ Standard, for the product alerts assigned by the Authorized Person - To recognize a reportable Adverse Event (AE) or safety information and ensure that the necessary information is forwarded to the Local Patient Safety Person (LPS) in Merck, Inc. within 24 hours EDUCATION - Background in Pharmacy, Life sciences, Pharmacology, Medicine or a related scientific discipline - Background in clinical project management I clinical trial conduct I medicinal product distribution - Fluent spoken and written English PROFESSIONAL & TECHNICAL SKILLS - At least 4 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing/QA operations, Distribution Warehouse management or clinical development activities - Experience in Good Distribution Practices and Distribution Activity - Knowledge in local laws and local regulations - Understanding of the drug development process with proven records in the area of regulatory compliance (GMP/GDP) and/or quality assurance systems - Understanding of clinical outsourcing and manufacture contract - Willingness and enthusiasm to share knowledge - Time flexibility - Excellent negotiation and influencing skills - Ability to prioritize and work in a rapidly changing environment.

Mumbai

 Merck Group - Manager - Quality  

 Merck Group - Manager - Quality   ,Job Description for  Merck Group - Manager - Quality   in Merck Group in  Mumbai for (5-8) years of experience. Apply Now!

Job Description for  Merck Group - Manager - Quality   in Merck Group in  Mumbai for (5-8) years of experience. Apply Now!