Job Posting: CMO Quality Associate Manager at Merck Limited
About Merck Limited:
Merck Limited, established in India in 1967, is a leading pharmaceutical and chemicals company. Merck Group holds 51% of the share capital.
Position Details:
| Position Name | CMO Quality Associate Manager |
|---|---|
| Organization | Merck Limited |
| Location | Baddi, India |
| Job Type | Full-time |
| Salary | NA |
| Industry | Pharma/Healthcare/Clinical Research |
Application End Date: 30th July 2024
Qualifications:
| Education | Bachelor of Pharmacy, Bachelor of Technology in Biotechnology, or Master’s in Science (Chemistry) |
|---|---|
| Experience | 8+ years in pharmaceutical/biopharmaceutical industry, medical, or life sciences |
Role Description:
The CMO Quality Associate Manager plans and manages quality oversight for contract manufacturing organizations (CMOs). Key responsibilities include quality leadership, compliance, and ensuring product standards meet regulatory guidelines.
Key Responsibilities:
- Act as the main contact for external CMOs
- Serve as on-site quality representative
- Perform on-site investigations and prepare reports
- Maintain Annual Product Quality Reviews schedule
- Conduct periodic risk assessments
- Develop and maintain Quality Technical Agreements
- Evaluate and present monthly CMO quality metrics
- Support product investigations and regulatory audits
- Manage risk assessment and mitigation for CMOs
- Provide QA support for interdepartmental projects
- Support product transfers and compliance during manufacturing
Candidate Profile:
- Qualifications: Bachelor of Pharmacy, Bachelor of Technology in Biotechnology, or Master’s in Science (Chemistry)
- Experience: 8+ years in the relevant industry
- Skills: Technical writing, project management, problem-solving, strong communication, flexibility, and adaptability
- Preferred: Experience with external partners and understanding of compliance trends
How to Apply:
Interested candidates can apply by [inserting application method/link here].