Pharmacovigilance Quality Assurance Manager (PV QA)

Position Title:

Company: Medifodil Smart Pharma Solutions

Location:

Employment Type:

Experience

Expectation:

audits

Key Responsibilities

• Full ownership of PV QMS including SOP lifecycle, deviations, change control and quality

metrics

• Leading all audit types such as:

• Internal PV audits

• Vendor audits

• Client qualification audits

• Regulatory inspections (EMA, MHRA, USFDA, CDSCO)

• Mock inspections and readiness exercises

• Preparing audit plans, checklists, reports, RCA and CAPA

• Managing end-to-end CAPA lifecycle

• Reviewing and approving SOPs, templates and controlled documents

• Conducting quality reviews of PV processes, safety systems and documentation

• Ensuring continuous inspection readiness

• Training, mentoring and guiding QA team members

• Driving continuous improvements and compliance initiatives

Qualifications & Skill Set

• B.Pharm / M.Pharm / Life Sciences

• Deep understanding of GVP, ICH, 21 CFR Part 11 and EMA guidance

• Extensive experience in PV audits, QMS, CAPA and RCA tools

• Excellent leadership, communication and client interaction skills

Apply: