Requirement of Corporate QA manager @ Allergan

Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs — and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.

Post: Corporate QA manager

Job Description:
1. Monitor the Quality related activities at all the Manufacturing sites of Allergan India & Allergan Healthcare and ensure complete compliance to WWQA and the respective MoH standards
2. Oversee product imports, release, distribution, post market surveillance (Non Medical) activities and Quality issues for Allergan India & Allergan Healthcare.
3. Management of Quality System in India & export markets in compliance with the local government laws, Ministry of Health (MOH) and the Allergan Worldwide Quality Assurance (WWQA) requirements. 4. Responsible for set up, training and monitoring of Good Distribution Practice (GDP) compliance for distributors in India & export market to ensure compliance to Worldwide Quality Assurance (WWQA) and country Ministry of Health (MOH) requirements.
5. Participate in new business projects in Allergan India & Allergan Healthcare to define QA procedures and resource requirements and take the appropriate actions to support the on going business needs. 6. Set up and manage Standard Operating Procedures (SOP) to ensure that SOPs are in place and operational. Coordinate with Global , local staff to ensure Company wide compliance.
7. Quality oversight of the third party entities in India for manufacturing, distribution, storage, testing and other such activities of Allergan products.
8. Participate in Quality and Compliance related matters in India region and also to make recommendation/decision on compliance issue.
9. Support/Mange potential market corrective actions
10. Interaction and prepare communication with Ministry of Health (MOH) for product issues and manage Ministry of Health (MOH) audit 11. Support the Supply Chain and Logistics Teams on all matters pertaining to Quality 12. Facilitate Quality certifications in conjunction with the Country Business Plans.

Candidate Profile:
Coordinate review of WWQA Standard and SOP to ensure alignment of Asia Pacific & WWQA requirements at all manufacturing and distribution sites in the India Region Review and approve SOP & Form to ensure compliance with both the Allergan WWQA and the COUNTRY regulatory requirements for operations of Allergan entities in India region. Implement WWQA initiatives or requirements for India. Conduct investigation and communicate quality issues to WWQA. Report and follow up product issues with manufacturing plants. Assist in preparation of Quality Plan and execution of the plan in the Country. Develop and coordinate GMP (GWP and other Global Standards) and technical training requirements for all Allergan entity employees. Prepare monthly report and conduct periodic trend review on all quality data Monitor applicable MOH trend and upcoming regulations

Additional Information:
Experience: 9-14 years
Location: Bangalore
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 23rd June, 2012