Quality Assurance Manager
- Infosys
- 5 to 9 Yrs
- Mohali, Chandigarh
- 3 months ago
- Email to a friend
- Report this job
Job Description
- The role of QMS Manager (Pharmacovigilance (PV)/GCP Auditing) based in Chandigarh, India requires you to perform various Quality Assurance activities either independently or in collaboration with the Quality Head. Your responsibilities include managing quality issues, events, deviations, and CAPAs, as well as conducting Root Cause Analyses (RCAs) or guiding staff in performing them. You will also be involved in developing CAPA plans and ensuring their implementation, planning audits based on risk assessment, and maintaining the audit planner in compliance with GVP and GCP requirements. Additionally, you will be responsible for preparing audit schedules, conducting internal audits and vendor audits, managing controlled documents such as SOPs and templates, and liaising with Project Leads/Functional Heads to ensure the implementation of relevant KPIs and metrics. Furthermore, you will review quality and compliance data from various projects, perform trend analyses, interpret the analyses, and engage in computer system validation activities. It is important to note that this is a suggestive list of responsibilities, and additional tasks may be assigned as required. To be successful in this role, you should possess a degree in Life Sciences disciplines such as Pharmacy, Microbiology, Biochemistry, or Biotechnology. A minimum of 5-6 years of experience in Pharmacovigilance, GCP, and Quality Assurance is essential. Proficiency in English, especially written English, is required along with an auditing certification (e.g., ISO lead auditor/assessor certification) and experience in planning audits using a risk-based approach. You should have expertise in conducting RCAs, developing CAPAs, and knowledge of drug safety, GCP, and regulatory requirements. Excellent written and verbal communication skills, attention to detail, a dedication to delivering high-quality work, effective multitasking abilities, flexibility, prioritization skills, and the ability to work under pressure are all crucial for this role. You should also be capable of working independently or as part of a team, possess strong problem-solving and decision-making skills, be adept at interpreting and presenting data, and have proficiency in using MS Office suite (Word/Excel/PowerPoint). Willingness to travel as required is also expected for this position.,
Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Quality Assurance ManagerContact Details:
Company: YD Talent SolutionsLocation(s): Mohali, Chandigarh+ View Contact
Keyskills: Quality Assurance Pharmacovigilance CAPAs Auditing SOPs Trend Analysis Computer System Validation Regulatory Requirements Communication Skills Data Analysis MS Office
Fraud Alert to job seekers!
₹ Not Disclosed
Similar positions
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in