Quality Assurance Specialist

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