Senior Executive - QA QMS

Role & responsibilities

Key Responsibilities

Quality Management System

• Manage QMS elements: change control, deviations, CAPA, OOS/OOT, market complaints, and incident investigations.
• Review and approve investigations, root cause analyses, and CAPA effectiveness checks.
• Track timelines and closure of QMS records, and ensure data integrity throughout.

Documentation and Compliance

• Review, issue, and control SOPs, master documents, and formats, including the document lifecycle and archival.
• Prepare and review Annual Product Quality Reviews (APQR).
• Support the Quality Risk Management program (FMEA, risk assessments).
• Maintain the training matrix and coordinate GMP training programs.

Sterile / Injectables Focus

• Oversee QMS aspects related to aseptic processing, media fills, environmental monitoring excursions, and sterility assurance.
• Review impact assessments for cleanroom, HVAC, utilities, and equipment-related deviations and changes.
• Support the contamination control strategy (per EU Annex 1).

Audits and Inspections

• Participate in regulatory inspections, customer audits, and internal audits.
• Prepare responses to audit observations and track commitments to closure.
• Support self-inspection programs and vendor/supplier audits.

Other

• Support validation and qualification oversight (process, cleaning, equipment, computerized systems).
• Generate QMS metrics and trend reports for management review.
• Coordinate with Production, QC, Engineering, Microbiology, and Regulatory Affairs.

Qualifications

• B.Pharm / M.Pharm / M.Sc (Chemistry, Microbiology, or related life sciences)

Experience

• 48 years in Quality Assurance within a sterile injectables facility, with strong hands-on QMS exposure.
• Experience facing USFDA/EU-GMP inspections is preferred.

Skills and Competencies

• Thorough knowledge of cGMP, Schedule M, 21 CFR Parts 210/211, EU-GMP (especially Annex 1), and ICH Q9/Q10
• Strong understanding of data integrity (ALCOA+) and electronic QMS tools (e.g., TrackWise, Veeva)
• Investigation and root cause analysis skills (5-Why, Fishbone)
• Clear technical writing, attention to detail, and cross-functional communication
• Ability to work under inspection pressure and meet tight timelines

Preferred candidate profile