Quality Assurance Specialist

4 weeks ago

Chandigarh, Chandigarh, India YDTS - Digital Transformation Solutions Full time

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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