Post : Manager - Global Quality
Job Description:
Role Summary :
Provides quality leadership and compliance oversight to the clinical products manufactured and tested by Syngene International for BMS and works collaboratively across the organizations.
Ensure that the BBRC and Syngene International manufacturing and testing adhere to BMS Quality standards and Good Manufacturing Practice regulatory requirements.
Role Summary :
Provides quality leadership and compliance oversight to the clinical products manufactured and tested by Syngene International for BMS and works collaboratively across the organizations.
Ensure that the BBRC and Syngene International manufacturing and testing adhere to BMS Quality standards and Good Manufacturing Practice regulatory requirements.
Key responsibilities:
• Oversees all GMP activities conducted by BBRC and Syngene associated with the manufacture and analytical testing of products, and conduct of stability studies (in support of development and registration), and the review of related documentation to ensure conformance to GMP, BMS policies and procedures, and government regulations.
• Reviews all quality non-conformances, ensures that deviation investigations are handled in a timely manner and manages timely implementation of effective corrective and preventative actions.
• Reviews & approves BBRC SOPs, reviews Syngene SOPs as applicable, and conduct internal audits as required.
• Brings to the attention of the BMS Quality Unit in the USA information relating to the impact of legislation on the functions of the site. Informs immediately of significant issues that might impact product quality or patient safety.
• Participates in Regulatory Agency inspections impacting BMS products and third party inspections as required.
• Provides GMP/Quality training.
• Provide guidance on GMP issues, interpretation of regulations and maintain awareness of regulatory trends and industry practices.
• Monitors quality metrics and participate in the BMS/BBRC/Syngene Quality Council to drive continuous improvement of the pharmaceutical quality system.
• Co-lead monthly internal Quality Forum with Syngene Quality
• Recruits and trains staff to carry out all functions of the Quality role. Periodically reviews the performance of direct reports with regards to the achievement of goals, objectives and behaviors.
• Oversees all GMP activities conducted by BBRC and Syngene associated with the manufacture and analytical testing of products, and conduct of stability studies (in support of development and registration), and the review of related documentation to ensure conformance to GMP, BMS policies and procedures, and government regulations.
• Reviews all quality non-conformances, ensures that deviation investigations are handled in a timely manner and manages timely implementation of effective corrective and preventative actions.
• Reviews & approves BBRC SOPs, reviews Syngene SOPs as applicable, and conduct internal audits as required.
• Brings to the attention of the BMS Quality Unit in the USA information relating to the impact of legislation on the functions of the site. Informs immediately of significant issues that might impact product quality or patient safety.
• Participates in Regulatory Agency inspections impacting BMS products and third party inspections as required.
• Provides GMP/Quality training.
• Provide guidance on GMP issues, interpretation of regulations and maintain awareness of regulatory trends and industry practices.
• Monitors quality metrics and participate in the BMS/BBRC/Syngene Quality Council to drive continuous improvement of the pharmaceutical quality system.
• Co-lead monthly internal Quality Forum with Syngene Quality
• Recruits and trains staff to carry out all functions of the Quality role. Periodically reviews the performance of direct reports with regards to the achievement of goals, objectives and behaviors.
Candidate Profile
• M.S. or B.S. degree in Chemistry, Pharmacy, or related discipline
• Excellent knowledge of English and Hindi languages
• Minimum 12 years of relevant experience within the pharmaceutical or healthcare industry, including 5+ years’ experience in a GMP/GLP regulated function
• Broad experience with regulatory and GMP standards associated with process control and validation, manufacturing and packaging, testing
• Strong knowledge of US Food and Drug, EU, and other health authority regulations
• Experience in R&D environment and in dealing with regulatory agencies
• Proven managerial experience
• Ability to work, resolve complex issues and influence others in a complex organizational matrix
• Excellent decision-making skills, demonstrated leadership skills, and strong interpersonal skills
• M.S. or B.S. degree in Chemistry, Pharmacy, or related discipline
• Excellent knowledge of English and Hindi languages
• Minimum 12 years of relevant experience within the pharmaceutical or healthcare industry, including 5+ years’ experience in a GMP/GLP regulated function
• Broad experience with regulatory and GMP standards associated with process control and validation, manufacturing and packaging, testing
• Strong knowledge of US Food and Drug, EU, and other health authority regulations
• Experience in R&D environment and in dealing with regulatory agencies
• Proven managerial experience
• Ability to work, resolve complex issues and influence others in a complex organizational matrix
• Excellent decision-making skills, demonstrated leadership skills, and strong interpersonal skills
Additional Information
Experience : 5 years
Qualification : B.Pharm, B.Sc, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Quality
End Date : 30th April, 2019
Experience : 5 years
Qualification : B.Pharm, B.Sc, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Quality
End Date : 30th April, 2019
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