Quality Assurance Specialist

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.,