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 : Quality Assurance Manager
Primary Function / Primary Goals / Objectives:
• Provide support to Regional QA Manager in planning to maintain and effective Quality system.
• Take lead in documentation, recording and archival of Quality documents.
• Identify potential cases of non-conformance internally and externally that could impact ADD-India business continuity.
• Effective planning and execution of requirements as per Abbott Diagnostics Division QS requirements (Q01.07)
• Provide support to Regional QA Manager towards effective strategy planning to mitigate possible business risk originating from deviations to meet quality requirements.
Major Responsibilities:
• Implementation of divisional Quality policies in Indian affiliate and deviation (if any) tracking.
• Ensure Quality objectives of ADD-India are met.
• Assist Regional QA Manager in keeping quality management system up-to-date for ADD-India
• Responsible for the communication and documentation of internal and external compliance-related information including changes impacting business continuity of ADD-India.
• Document Audit non-conformances, evaluates impact, propose corrective/preventive actions and execution of effectiveness check in a time-bound manner.
• Coordination between internal functions to ensure all activities related to Quality compliance is completed in a time-bound manner.
• Ability to understand, interpret, and apply document control principles and processes to ensure compliance with Corporate, Regional, ISO regulations and standards with unyielding integrity.
• Communicate non-conformances to owners, managers, directors, and upper management.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support to Regional QA Manager towards effective planning of Inspection activities and reporting.
• Update local procedure, forms based on internal process modification or developments.
• Performs supplier assessment prior contract initiation.
• Lead qualification and control of new Distributor as per existing processes and assist existing distributors towards compliance to divisional requirements.
• Provide adequate support to RA/QA manager towards drafting Quality agreements/contracts.
• Provide daily QA oversight for third party logistics providers and spare parts depots.
• Support management review to assess health of ADD India quality systems
• Implementation of divisional Quality policies in Indian affiliate and deviation (if any) tracking.
• Ensure Quality objectives of ADD-India are met.
• Assist RA/QA Manager in keeping quality management system up-to-date for ADD-India
• Responsible for the communication and documentation of internal and external compliance-related information including changes impacting business continuity of ADD-India.
• Document Audit non-conformances, evaluates impact, propose corrective/preventive actions and execution of effectiveness check in a time-bound manner.
• Coordination between internal functions to ensure all activities related to Quality compliance is completed in a time-bound manner.
• Ability to understand, interpret, and apply document control principles and processes to ensure compliance with Corporate, Regional, ISO regulations and standards with unyielding integrity.
• Communicate non-conformances to owners, managers, directors, and upper management.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support to RA/QA manager towards effective planning of Inspection activities and reporting.
• Update local procedure, forms based on internal process modification or developments.
• Performs supplier assessment prior contract initiation.
• Lead qualification and control of new Distributor as per existing processes and assist existing distributors towards compliance to divisional requirements.
• Provide adequate support to RA/QA manager towards drafting Quality agreements/contracts.
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Candidate Profile
• Bachelor's degree in life sciences or pharmacy (Biochemistry, Biotechnology, Microbiology, Immunology, Medical technology, pharmacy, Pharmacology) is preferred. Masters in above field will be preferred.
• Minimum 3-4 years of experience in handling corporate Quality management system function.
• QA experience in manufacturing will be an added advantage.
• Internal Quality (ISO 9001:2008 or later standard) Auditor certification.
• 2+ year association with a regulated industry (Healthcare preferred). Knowledge of In-vitro medical devices or Medical devices will be preferred.
• Strong working knowledge on requirements of Drugs and Cosmetics Act, 1940 and Rules, 1945.
COMPETENCIES :
1. Effective coordination skills with all internal functions of ADD-India.
2. Document control and archiving.
3. Effective Audit planning.
4. Good communication skills and basic working knowledge of MS-office.
Job Summary
Location: Mumbai , Maharashtra , India
Experience: 3-4 year
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: QA
Last Date: 8th January, 2018
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