posted 18 april 2025reference number JPC - 107172next stepsjob detailsDear JobSeekers, We have an opportunity for PV Auditing & QMS Manager with a leading CRO. Mode of Working: HybridLocation: ChandigarhExperience: 5-6 years in PV and/or GCP and Quality Assurance 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:xe2x80xa2 Management of quality issues/events/deviations and CAPAsxe2x80xa2 Performing RCAs and/or providing guidance to the staff in performing RCAsxe2x80xa2 Developing CAPA plans and/or providing guidance to the staff in developing and implementing CAPAsxe2x80xa2 Planning audits using a risk-based assessment and maintaining the audit planner in accordance with applicable GVP and GCP requirementsxe2x80xa2 Preparing audit schedules and performing internal audits and audits of vendorsxe2x80xa2 Maintaining/managing controlled documents such as SOPs, templates etc.xe2x80xa2 Liaising with Project Leads/Functional Heads for ensuring implementation of applicable KPIs/metricsxe2x80xa2 Reviewing the quality and compliance data of various projects; performing trend analyses and interpretation of analysesxe2x80xa2 Computer system validation activities Qualifications and skills: xe2x80xa2 Degree in any of the Life Sciences disciplines (Pharmacy, Microbiology, Biochemistry, Biotechnology etc.)xe2x80xa2 Experience of 5-6 years in PV and/or GCP and Quality Assurancexe2x80xa2 High level of proficiency in English, particularly written Englishxe2x80xa2 Auditing certification (e.g. ISO lead auditor/assessor certification)xe2x80xa2 Auditing experience, specially planning for audits using risk-based approachxe2x80xa2 Experience in performing RCAs and development of CAPAsxe2x80xa2 Working knowledge of drug safety/GCP/regulatory requirementsxe2x80xa2 Strong written and verbal communication skillsxe2x80xa2 Detail orientedxe2x80xa2 Passion for delivering high quality workxe2x80xa2 Ability to manage multiple and varied tasks effectivelyxe2x80xa2 High level of flexibility and ability to prioritize workxe2x80xa2 Ability to perform under stringent timelinesxe2x80xa2 Ability to work independently or as a team memberxe2x80xa2 Excellent problem-solving skills and decision-making skillsxe2x80xa2 Ability to understand, interpret, analyse and present dataxe2x80xa2 Computer proficiency: proficiency in the use of MS Office suite (Word/Excel/ Power Point)xe2x80xa2 Ability and willingness to travel, as needed Interested candidates can share CVs at jhelam.s@randstad.inexperience 7 ...