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 solid 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
Solid understanding of data integrity (ALCOA+) and electronic QMS tools (e.g., TrackWise, Veeva)
Investigation and root cause analysis skills (5-Why, Fishbone)
Transparent technical writing, attention to detail, and cross-functional communication
Ability to work under inspection pressure and meet tight timelines

Preferred candidate profile

📌 Senior Executive Qa Qms Hyderabad (India)
🏢 Aspiro Pharma
📍 India