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Opportunity to Work as a Plant Quality Assurance Manager in Abbott

 

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Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.

Post: Plant Quality Assurance Manager

Job Description:
1. Lead the quality assurance department in Abbott Manufacturing India. The department consists of four sections : Analytical Laboratory, Microbiology Laboratory, Quality System, Validation and Compliance.
2. Lead by example and therefore ensure site compliance to all policies and procedures within the Abbott Nutritional Organization.
3. Plan, manage and control the Quality Assurance Department and ensure all budgets are achieved as per plan.
4. Ensure that products are effectively inspected/tested and that product/process quality data are reviewed to determine conformance with specifications; thereby accepting or rejecting products and where appropriate in consultation with Site Director and Abbott International Quality Assurance Nutritional Division.
5. To act as the final QA Authority on accept/reject decisions.
6. To ensure prompt attention of the Site Director where areas of risk in the production or QA operations which may have an adverse effect on product quality and/or safety.
7. To regularly audit the production and Q.A. operations for compliance with applicable policies and procedures and to co-ordinate and document a corrective action program.
8. Co-ordinate the Plant Quality Related Goals Programs.
9. Maintain up to date specifications and procedures in agreement with Abbott and legal requirements of markets supplied.
10. To liaise with and seek appropriate advice from and report when necessary to division AIQA.

11. To endorse all GMP/QA/Production training activities undertaken on site and to ensure effectiveness and consistency.
12. Ensure adequate training and development is provided to all QA personnel.
13. Ensure that all market regulatory requirements regarding cans, analysis, certificates of analysis and registration are in-place and correct.
14. Ensure the laboratories are operated effectively and efficiently with regards to timely testing and release of raw materials, intermediates and finished products.
15. Participate in projects as assigned by the Plant Manager or ANIQA Nutritional Division Quality Head and ensure the implementation of new management tools in the company. Ensure all projects are carried out as per agreed schedule.
16. Liaise with the Human Resources Department in the recruitment and selection of personnel for the Quality Department; ensure compliance with Company policies and procedures and legislation for recruitment and selection.
17. Ensure continued implementation of the Performance Excellence initiative throughout the Quality Department by completing all goals, performance reviews and growth plans as scheduled.
18. Drive and implement continuous improvements to enhance quality and food safety in our products in a cost effective manner.
19. Follow all Health and Safety Rules and Regulations in the plant.


B. Major Duties And Responsibilities:
1. To ensure Abbott Nutrition International Quality Assurance Policies and Procedures are fully implemented and operational for all raw materials, finishing supplies, in-process and finished product.
2. Ensure all products produced comply with the product Master Specifications.
3. She/he is responsible to release all products within the agreed time scale allowed for analysis.
4. Plan, manage and control the Quality Assurance Department and ensure all budgets are achieved.
5. Where possible identify new methods/techniques and equipment which can be used to assist in making the department more cost effective and efficient.
6. Ensure full compliance with Abbott and Regulatory Requirements.

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For the Quality Manager:
1. Not wanting to limit to 4 sections as those are just the sections we highlighted and those sections contain many different aspects within them as well. Example:
Management responsibility for laboratories which include chemical, biological, sterility and environmental testing. Overall responsibility to maintain high quality levels on all products while achieving high efficiency. Responsible for GMP compliance, manufacturing quality, laboratory support ,product testing and release, Vendor Quality, Documentation at the site and quality planning.

4. Site Director referenced should be Regional Director (?) unless you are referring to the Operation Plant Mgr.
5. Subject only to division Quality Assurance's direction, the incumbent has the final authority to release or otherwise dispose of finished product and has release responsibility for products manufactured at the site.
6. Add: Critical to GMP challenge is the identification and elimination of any contamination sources (microbial, extraneous material).

Add:
Responsible for implementing and maintaining the effectiveness of the Quality System.
Monitors, audits and approves facilities and manufacturing operations for conformance with established procedures and requirements of the Corporate and Governmental GMPs, Low Acid Food and Infant Formula Regulations.
Interfaces directly with Regulatory Inspectors to maintain plant/product certification. Monitors and reports on all activities of the plant to Division QA.

Add Major Responsibilities:
Responsible to assure identification and implementation of statistically driven quality programs as well as to provide assistance in continuous improvement in all manufacturing areas. Coordinates or aids in problem evaluation and problem solving.
Responsible for the plant validation program and assures compliance with AN validation policies.
Provides a Vendor Quality function to assure that suppliers have appropriate quality systems and process controls to guarantee the delivery of usable inventories of the needed quality.

Desired Profile:
• 5 years experience as a Chemist / Microbiologist / Food Scientist in a manufacturing QA Department.
• 5 years front line management experience.

Additional Information:
Experience: 5-6 Years
Location: Mumbai
Education: M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production

Job Code: 95934BR
End Date: 19th Sept., 2011

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