Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified 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: Supplier Quality Assurance - Compliance Auditor
Job Description:
Responsible to assess compliance of systems and facilities per applicable regulations at Suppliers and Third Party Manufacturers through audits and assessments, assuring compliance to regulatory requirements and compliance to Abbott specifications. Maintenance of an approved supplier list and participate in the supplier management process, including BSE/TSE risk assessments. The position serves a strategic and tactical purpose for Abbott and must achieve a difficult balance of involvement and objectivity. Support is also provided to internal operations for quality issues related to suppliers and in the resolution of supplier exceptions to Abbott specifications. Auditing serves to provide feedback in the form of audit observations, formulation of recommendations, review of corrective actions and to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the Supplier or Third Party Manufacturer. The position also provides an active role within the corporation as experts in GMP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.
The function of Supplier Quality Assurance (SQA) Compliance Auditor is to provide direction and leadership for compliance with US and foreign regulation requirements and provide constructive evaluation of quality related systems for Suppliers and Third Party Manufacturers that provide materials, services and products to GPO. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers who provide final products to GPO. The SQA Compliance Auditor is also responsible for providing support to GPO QA regional plants in the resolution of issues related to suppliers and in the review/resolution/approval of supplier exceptions to specifications. Their leadership in the area of GMP compliance and quality assures that activities are performed and documented per systems and procedures in accordance to applicable quality and regulatory requirements intended to assure the quality, effectiveness and safety of our products.
Candidate Profile:
Bachelor Degree, Chemistry, Pharmacy, Biology or Microbiology, Engineering or other technical/scientific or industry experience (>8 years) with sufficient exposure to pharmaceutical or related industries.
Must have a technical background and requires a thorough understanding of the audit process and an extensive knowledge of worldwide requirements related to GMP regulations for quality systems and compliance. Additionally, the individual must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
The individual must have excellent oral/written communications skills. Personal skills needed include interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self reliance, organizational/administrative skills and sound judgment. Persuasive, effective communication skills are essential with an ability to work effectively outside of the company and across divisional and technical areas.
Four or more years in Quality Assurance with some project management experience and one or two more years in another function in the pharmaceutical, medical device/nutritional or related industry. One year in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to be at least 6 years. ASQ CQA desired, not required.
The individual must be able to work independently, without direct supervision or guidance and to exercise judgment in determining when complex issues merit management involvement. Decisions must be made upon up to date technical/business knowledge and skills.
This role indirectly supports product marketing activities and management of financial goals for GPO. Effective performance helps to prevent regulatory vulnerabilities that could result in product quality and/or regulatory problems that can negatively affect Abbott's worldwide image, performance of Abbott earnings and stock, and customer confidence and loyalty.
The suppliers and Third Party Manufacturers audited by SQA Compliance Auditors account directly or indirectly for billions of Abbott sales considering the PPG direct sales and sales of sister division products utilizing GPO supplied materials. This position is accountable for minimizing a high potential negative impact on Abbott associated with inadequate recognition of internal and external systems that are either nonexistent, poorly designed or functioning improperly.
Additional Information:
Exp: 8-10 yrs
Location: Mumbai
Education: B.Pharm, B.Sc - Chemistry, Biology, Microbiology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Keyword or Job ID: 104633BR
End Date: 5th March, 2012
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