Quality Assurance Officer

About the role

The Quality Assurance Officer will ensure that all manufacturing activities comply with current Good Manufacturing Practice (cGMP) standards and that documentation is accurate and up‑to‑date.

Key responsibilities

• Monitor daily compliance with cGMP across manufacturing areas, equipment and systems.
• Review batch manufacturing records (BMRs) online to verify SOP adherence, signatures and dates.
• Prepare and execute qualification protocols (DQ/IQ/OQ/PQ/RQ) and process validation protocols.
• Perform in‑process quality control checks such as friability, uniformity of mass, disintegration, moisture content, hardness and thickness tests.
• Monitor environmental conditions (temperature, pressure, relative humidity) to ensure they remain within specifications.
• Identify, investigate and document deviations in manufacturing processes.
• Maintain document control, filing, archiving and issuance of controlled documents.
• Write and maintain SOPs for QA and other departments.

Required profile

• Entry‑level candidate with at least 24 months of relevant experience.
• Knowledge of cGMP requirements and manufacturing documentation.
• Familiarity with equipment qualification and process validation procedures.
• Ability to conduct and interpret in‑process QC tests.

Required skills

• cGMP compliance
• Equipment qualification (DQ/IQ/OQ/PQ/RQ)
• Process validation
• In‑process QC testing (friability, uniformity, disintegration, moisture, hardness, thickness)
• Environmental monitoring (temperature, pressure, humidity)
• Document control and record keeping
• SOP authoring and maintenance