Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd. Merck Specialities Pvt. Ltd., the wholly owned Indian subsidiary of Merck KGaA, was incorporated in 2005.
Post : Associate Manager, CMO Quality
Job Description
This position will be responsible for planning and managing, QA activities for contract manufacturing operations (CMOs) to meet compliance and business requirements and anticipate future needs. This position will also work directly with internal and external stakeholders to provide sustaining quality and compliance and routine support related to current commercialized products. Ensures that performance and quality of products conform to established standards and regulatory guidelines to ensure patient safety. This position requires both domestic and international travel up to 30% of time.
Key Accountabilities
• Manage deviations, investigations, CAPA measures, change control, ERP Master Data and Artwork Management
• Generate and maintain Product Quality Reviews
• Prepare monthly CMO quality metrics for management oversight review
• Participates in and provides support to cross-functional teams in relation to product investigation, regulatory audits/inquires, implementation of new/revised GxP guidelines and improvement initiatives
• Implements appropriate standards and practices for quality of contract manufacturing operations and ensures alignment with industry best practices
• Generate and maintain Quality Technical Agreements (QTAs)
• Ensures alignment with PQS for implementation of GxP activities with a focus on external GMP manufacturing and GDP for commercial products.
• Manages quality risk assessment process for CMOs and efforts to execute risk mitigation plans
• Provide QA support for interdepartmental project work
• Reviewing and preparing the batch documentation for the market release by the Qualified Person as applicable including clarifying questions with the CMO partners.
Candidates Profile :
Required Qualification : Graduate / Post Graduate in Pharmacy or Science
Job Specific Competencies & Skills : Able to successfully influence others within project teams regarding quality or compliance concerns. Broad insight of bio & pharmaceutical manufacturing. Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment. Excellent verbal & written communication skills in English.
Work Experience Required :
• Minimum 5 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences required
• Demonstrated ability to work across matrix organization in international and multi-cultural environment
• Experience in working with external partners (e.g. contract manufacturing organizations, contract laboratories and suppliers) is preferred
• Good understanding of external compliance trends and ability to address needs based on external demand
• Strong knowledge of technical writing and project management skills,
• Excellent organization and presentation skills
Additional Information
Experience : 5 years
Location : Mumbai
Qualification : M.Pharm, M.Sc, B.Pharm, B.Sc
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CMO Quality
End Date : 20th July, 2019
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