Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Post : Senior Manager Third Party Operations (India)
Job Description
Job Summary
Reporting to the Global Director, Corporate Audit & External Mfg., the Senior Manager, External Manufacturing India will be responsible to ensure that the quality of all products manufactured for Apotex by 3rd party vendors meets all applicable regulatory requirements. The position interacts with high level management at third party manufacturers and the person appointed will act as a representative of Apotex. The role entails developing relationships, negotiating issues and communicating Apotex quality requirements with third party manufacturers. There is significant interaction with many internal business and manufacturing organizations and it will be necessary to work closely with cross functional teams such as Co-Development, Business Development, New Product Launch teams and Regional External Quality teams.
Job Responsibilities
- Liaises with internal quality functions and other Regional External Quality teams on issues relating to third party manufacture in India. Acts as primary contact with third party manufacturers on GMP issues and liaises with third party manufacturers supporting resolution of product quality Issues.
- Establishes a strong relationship with third party organizations. Implements quality systems to monitor key quality metrics to enable evaluation of trends and continuous assessment of compliance risks.
- Ensures third party manufacturers in India comply with the terms of the quality agreements. Performs periodic reviews with third Party manufacturers and ensures updates are implemented.
- Receives notifications of significant quality incidents from third party manufacturer and agree actions as required. If necessary, initiates the ‘Incident Escalation’ process. Collaborates closely with Regional External Quality functions on incident resolution.
- Facilitates the Apotex corporate audit process at key third party manufacturers. Defines appropriate action plans for improvement and periodically follows up and communicates action closures.
- Provides oversight of third party manufacturer’s investigations into customer complaints, quality incidents and deviations to ensure root cause are identified and effective CAPAs are implemented.
- Implements and applies a risk–based approach to third party manufacturing operations quality oversight and seek efficiencies in operations without compromise to product quality. Promotes continuous improvement activities.
- Assures the quality and compliance of New Products Supply by participating in and supporting due diligence assessments, technical transfers and Business Development projects within the region. Responsible for Quality oversight of technical transfer operations in the region.
- Oversees the regulatory and compliance status of products manufactured by third party manufacturers in India. Assures changes that impact Apotex products are notified appropriately and implemented in compliance to Apotex regulatory filings. Ensures adherence to local compliance requirements.
- Provides support to the Manager, Audit and Systems to ensure the GMP audit program in the region meets compliance expectations for all key raw materials, intermediates, products and services supplied to Apotex.
- Works with internal and external Stakeholders to ensure that Third Party Strategy is developed in accordance with Regulatory and GMP requirements. Contributes to the development and improvement of External Quality Operations.
- Collaborates with Apotex manufacturing sites, Apotex Country Offices and Apotex affiliate organization to develop global strategies on third party management and quality.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
Candidate Profile
1. A minimum of a Bachelor degree in Microbiology, Chemistry, Pharmacy or related science is required. A minimum of 14 years’ experience is required in the pharmaceutical industry, with relevant QA/QC /Manufacturing experience, preferably with multiple dosage form, which would include a minimum of 8 years applicable QA experience.
2. Comprehensive knowledge of global cGMP and QA/QC systems associated with the manufacture of human drug products.
3. Experience of managing the day to day quality Issues in a drug product manufacturing plant.
4. Able to act independently, to take initiative and proactively seek resolution of quality issues.
5. Excellent organizational skills, analytical thinking and inter-personal communication skills.
6. Demonstrates personal leadership and accountability. Is able to prioritize work for self and others and is able to accomplish work through others.
7. Must be able to travel frequently and occasionally at short notice to visit clients and contract manufacturers within the region.
Additional Information:
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Third Party Operations
End date : 25th July, 2018
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