
Quality Assurance Specialist
2 days ago
Job description for the position of Pharmacovigilance (PV)/GCP Auditing & QMS Manager
Performing QA activities (listed below) independently and/or in liaison with the Quality Head:
• Management of quality issues/events/deviations and CAPAs
• Performing RCAs and/or providing guidance to the staff in performing RCAs
• Developing CAPA plans and/or providing guidance to the staff in developing and implementing CAPAs
• Planning audits using a risk-based assessment and maintaining the audit planner in accordance with applicable GVP and GCP requirements
• Preparing audit schedules and performing internal audits and audits of vendors
• Maintaining/managing controlled documents such as SOPs, templates etc.
• Liaising with Project Leads/Functional Heads for ensuring implementation of applicable KPIs/metrics
• Reviewing the quality and compliance data of various projects; performing trend analyses and interpretation of analyses
• Computer system validation activities
Note: This is only an indicative list, not an exhaustive list of responsibilities. Additional activities may need to be performed.
Qualifications and skills:
• Degree in any of the Life Sciences disciplines (Pharmacy, Microbiology, Biochemistry, Biotechnology etc.)
• Experience of 5-6 years in PV and/or GCP and Quality Assurance
• High level of proficiency in English, particularly written English
• Auditing certification (e.g. ISO lead auditor/assessor certification)
• Auditing experience, specially planning for audits using risk-based approach
• Experience in performing RCAs and development of CAPAs
• Working knowledge of drug safety/GCP/regulatory requirements
• Strong written and verbal communication skills
• Detail oriented
• Passion for delivering high quality work
• Ability to manage multiple and varied tasks effectively
• High level of flexibility and ability to prioritize work
• Ability to perform under stringent timelines
• Ability to work independently or as a team member
• Excellent problem-solving skills and decision-making skills
• Ability to understand, interpret, analyse and present data
• Computer proficiency: proficiency in the use of MS Office suite (Word/Excel/ Power Point)
• Ability and willingness to travel, as needed
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