Require Quality Manager at Merck Limited | M.Pharm, M.Sc, B.Pharm
Our businesses in U.S. and Canada operate as EMD Serono in Biopharma, MilliporeSigma in life science and EMD Performance Materials in the chemicals and high-tech materials business. Outside of the U.S. and Canada, we hold the rights to the name and the trademark “MERCK”. The businesses of Merck KGaA, Darmstadt, Germany are truly global, with 52,000 employees in 66 countries working on breakthrough solutions and technology.
Post : Quality Manager
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.
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), within 24 hours
• 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
• At least 5 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.
Experience : 5 years
Qualification : M.Pharm, M.Sc, B.Pharm, B.Sc
Location : Mumbai, Maharashtra
Industry Type : Pharma
Functional Area : Quality
End Date : 10th November, 2018
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