Key Responsibilities

OOS/OOT Investigation
- Review and investigate all OOS, OOT, atypical results, and laboratory incidents.
- Conduct Phase I and Phase II investigations in accordance with SOPs.
- Analytical QA Review:
- Review analytical raw data, worksheets, calculations, chromatograms, spectra, and laboratory notebooks.
- Verify compliance with analytical methods, specifications, SOPs, and pharmacopoeial requirements.
- Ensure completeness, accuracy, and traceability of analytical records.
- Audit Trail Review:
- Perform periodic audit trail review of computerized analytical instruments such as HPLC, GC, UV, FTIR, Dissolution, TOC, ICP-MS, and other software-enabled systems.
- Identify unauthorized activities, data deletions, repeated injections, backdating, or suspicious system events.
- Ensure compliance with data integrity requirements (ALCOA+ principles).
- Document observations and initiate investigations where required.
- . Instrument Calibration & Qualification:




- Review and monitor calibration schedules of laboratory instruments.
- Verify calibration certificates and traceability.
- Ensure timely calibration, preventive maintenance, and qualification of analytical equipment.
- Coordinate with engineering, vendors, and QC laboratories.
- Ensure compliance with current GMP, GLP, and Data Integrity guidelines.
- Review electronic records and user access management.
- Monitor compliance with 21 CFR Part 11 (where applicable), EU GMP Annex 11, and WHO Data Integrity guidance.
- Participate in data integrity assessments and gap closure activities.
- Compliance & Continuous Improvement:
- Support continuous improvement initiatives within QC and QA.
- Monitor quality metrics related to investigations and laboratory compliance.
- Ensure readiness for regulatory inspections at all times.

Perks:
- Paid time off

Work Location: In person

📌 Analytical Quality Assurance (Baddi)
🏢 Maya Biotech
📍 Baddi