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India Quality Manager
4 weeks ago
Reporting to the Senior Manager International Quality JAPAC, the India Quality Manager will be responsible for implementing and maintaining the Amgen Quality Management System within India. This is a crucial role focused on ensuring compliance with cGMP, GDP, and local regulations. You will oversee operations of local distributors and partners, act as the primary quality-related interface, and drive continuous improvement initiatives to maintain high standards across all operations.
Roles & Responsibilities
- Quality Management System: Implement the Amgen Quality Management System and identify opportunities for continuous improvement. You will also develop quality procedures that align with Amgen's standards, cGMP, GDP, and local regulations.
- Oversight & Compliance: Oversee the operations of local distributors and stockists, ensuring their activities are in full compliance with cGMP and GDP requirements. You will act as a quality-related interface for internal and external customers on issues such as change control, non-conformance, and product complaints.
- Supplier Management & Audits: Perform quality oversight and audits of key suppliers, including manufacturers, contract facilities, distributors, and logistics providers. You will apply advanced knowledge of Indian and global market regulations to assess supply security risks and support regulatory inspections as needed.
- Risk & Security: Collaborate with Risk Management and Product Security teams on handling counterfeit products, product tampering, theft, and diversion. You will actively participate in GMP intelligence to monitor local regulations and standards.
- Training & Communication: Develop and maintain Quality Agreements with local distributors and partners. You will also develop reports, provide necessary communications, and offer training to distributors and stockists.
Qualifications
- Pharmacist Registration in India, with a valid practicing certificate.
- In-depth knowledge and experience with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
- Experience with Quality Management Systems, including but not limited to change control, deviation, validation, complaints, disposition, and audits.
- Experience with Commercial Quality Operations and third-party management.
- Experience with distribution models and/or establishing new entity procedures is a plus.
Soft Skills
- Communication: The ability to effectively liaise with internal and external partners and provide clear reports and communications throughout the organization.
- Problem-Solving: Strong analytical skills to identify continuous improvement opportunities and address quality events.
- Compliance & Integrity: A strong focus on ensuring compliance with all regulatory and company standards.
- Leadership: The ability to lead and coordinate various quality-related activities and projects.
