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Work as Deputy General Manager at Apotex Inc


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Work as Deputy General Manager at Apotex Inc

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.  

Post : Deputy General Manager - CSV Computer Systems Validation

Job Description
Job Summary
Manage CSVC ,GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions teams of GIS Department and ensure the Compliance of all GxP impacting systems with respect to Validation, Management and Administration.  Planning, Coordination, Approval of Computerized System validation in collaboration with IS, QA and Business users.  Below mentioned Job responsibilities will be applicable for computer system validation GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions of ARPL, APIPL , BEC and Apotex Inc.

Job Responsibilities
• Develop, implement and maintain policies, local procedures and tools to achieve a consisitent risk based approach to computer system validation and Administration of Quality and R& D systems.
• Develop and implement 21 CFR Part 11 and any other related regulatory compliance strategy for new and existing systems, including remediation of legacy systems.
• Represent the regulatory inspections with respect to computer system validation, GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions.
• Participate as an Subject Matter Expert for computerized system validation and IT Compliance.
• Participate in projects,investigations, audits and improvement initiatives.
• Devise strategies and Lead CSVC and GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions.
• Setup operation processes for sustaining compliance and service delivery of GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions.
• Collaboration with Global CSVC and IS teams to harmonize CSVC and IS policies,procedures, processes across Apotex.
• Monitor, audit and assess department performance vs business objectives to implement improvements, determine continued relevance and anticipate opportunities.

• Ensure adherence of team members with all compliance programs and company policies and procedures.
• Ensure the computerized system validations and documentation as per GDP and QMS.
• Ensure Site & Global SOP’s shall be followed during Computer system validations and Administration GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions compliance as applicable.
• Review and Approve of documents in GIS.
• Follow QMS process in trackwise as per applicable SOP.
• Predictive compliance activities like review of regulatory guidance’s, regulatory observations etc.
• Maintain effective inter-personal relationship with Cross-functional department personnel.
• Work as Team member to achieve Goals and objectives of department.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance program, Global Quality policies and procedures,Safety and Environment policies and HR policies.
• All other duties as assigned by Superior.

Candidate Profile
• A minimum university graduate in BE/ B. Pharm / M Pharm / M. Sc. 
• Knowledge on CSV, Quality and R& D systemss, 21 CFR Part 11 and EU Annex 11.
• Knowledge on ICH Q7, GMP, and GAMP guidelines.
• Team work and collaborative skills.
• Proficient in verbal & written communication skills.
• Minimum 12 years of experience in GMP regulated Pharmaceutical Industry.
• Minimum 8 years of experience in people management.

Additional Information
Experience : 5+ years
Qualification : BE/ B.Pharm / M.Pharm / M.Sc
Location : Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th April, 2024

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