YDTS - Digital Transformation Solutions

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