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