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
As the Pharmacovigilance (PV)/GCP Auditing & QMS Manager, you will be responsible for independently performing QA activities in collaboration with the Quality Head. This includes managing quality issues, events, deviations, and CAPAs. You will be involved in performing Root Cause Analyses (RCAs) or guiding staff in conducting RCAs, as well as developing CAPA plans or assisting staff in implementing CAPAs. Planning audits based on risk assessments, maintaining audit schedules, and conducting internal audits and vendor audits are also part of your role. Your responsibilities will encompass maintaining controlled documents like SOPs and templates, liaising with Project Leads/Functional Heads to ensure implementation of relevant KPIs/metrics, reviewing quality and compliance data across projects, conducting trend analyses, and interpreting the results. Additionally, you will be involved in computer system validation activities. You should possess a degree in any Life Sciences discipline (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology), along with 5-6 years of experience in PV, GCP, and Quality Assurance. Proficiency in English, especially written English, is crucial. Holding an auditing certification (e.g., ISO lead auditor/assessor) and having experience in auditing, particularly in planning audits using a risk-based approach, are essential. Your skill set should also include experience in conducting RCAs and developing CAPAs, familiarity with drug safety/GCP/regulatory requirements, strong written and verbal communication skills, attention to detail, a commitment to delivering high-quality work, effective multitasking abilities, flexibility, and the capacity to work under strict timelines. You should be comfortable working both independently and as part of a team, possess excellent problem-solving and decision-making skills, and be proficient in understanding, interpreting, analyzing, and presenting data. Moreover, you must have proficiency in using the MS Office suite (Word, Excel, PowerPoint), a willingness to travel as required, and a passion for the responsibilities associated with the position. Please note that the mentioned responsibilities are indicative, and additional tasks may be assigned as needed.,