
QA Leader
1 week ago
**Job Overview:**
As a seasoned Quality Assurance Manager, you will be responsible for overseeing the quality management system (QMS) in our organization. Your primary objective will be to ensure compliance with pharmacovigilance (PV) and good clinical practice (GCP) regulations.
Key Responsibilities:
- Manage quality issues, events, and deviations, and develop corrective action plans (CAPAs).
- Perform root cause analysis (RCA) and provide guidance to staff members on conducting RCAs.
- Develop CAPA plans and implement them effectively.
- Plan audits using risk-based assessment techniques and maintain an audit planner according to applicable GVP and GCP requirements.
- Prepare audit schedules and conduct internal audits and vendor audits.
- Maintain controlled documents such as SOPs and templates.
- Collaborate with project leads and functional heads to ensure the implementation of relevant KPIs and metrics.
- Review quality and compliance data from various projects, perform trend analyses, and interpret the results.
- Participate in computer system validation activities.
Qualifications and Skills:
- Bachelor's degree in any Life Sciences discipline (Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.).
- Minimum 5-6 years of experience in PV and/or GCP and quality assurance.
- Excellent proficiency in English, particularly written English.
- Auditing certification (e.g., ISO lead auditor/assessor certification).
- Experience in auditing, especially planning audits using risk-based approaches.
- Strong written and verbal communication skills.
- Attention to detail.
- Passion for delivering high-quality work.
- Ability to manage multiple tasks effectively.
- High level of flexibility and prioritization skills.
- Ability to work under tight deadlines.
- Computer proficiency in MS Office suite (Word, Excel, PowerPoint).
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