Deputy General Manager- CSV Computer Systems Validation
Apotex Inc.
Full time- 8+ years
- Not Disclosed
- Bengaluru, India
- Post Date: Apr 05, 2024
- End Date: Jun 05, 2024
- 8+ years
- Not Disclosed
- Bengaluru, India
- Post Date:Apr 05, 2024
- End Date: Jun 05, 2024
Skills:
- bpharm
- mpharm
- Management
- Communication
Job Description:
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.
Qualification & Experience
- A minimum university graduate in BE/ B. Pharm / M Pharm / M. Sc.
- Knowledge, Skills and Abilities
- 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.
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