Senior Executive - QA QMS

Aspiro Pharma Ltd.; Hyderabad; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Aspiro Pharma Ltd. Hyderabad is seeking a senior QA professional to lead QMS activities across sterile injectables, manage deviations, CAPA, change controls, and regulatory inspections.

You will review investigations, ensure data integrity, prepare APQRs, and coordinate GMP training while aligning with global standards (cGMP, EU GMP Annex 1). Proficiency with TrackWise or Veeva is preferred, and strong cross‑functional communication is essential.

Qualifications

• B.Pharm / M.Pharm / M.Sc (Chemistry, Microbiology, or related life sciences)
• 48 years in Quality Assurance within a sterile injectables facility (as stated)
• Experience facing USFDA/EU-GMP inspections is preferred.
• Strong knowledge of cGMP, Schedule M, 21 CFR Parts 210/211, EU-GMP (Annex 1), and ICH Q9/Q10.
• Proficiency in data integrity concepts (ALCOA+) and electronic QMS tools.

Responsibilities

• 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.
• 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.
• 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).
• 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.
• 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.

Skills

cGMP

Schedule M

21 CFR Parts 210/211

EU-GMP Annex 1

ICH Q9/Q10

Data integrity (ALCOA+)

eQMS tools (TrackWise)

eQMS tools (Veeva)

Investigation & root cause analysis

Cross-functional communication

Inspection pressure handling

Education

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

Tools

TrackWise

Veeva

Job description

Role & 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