QA Officer ((Pharmaceutical)

· Ensuring that all GMP activities are performed in accordance with the regulatory and legal requirements and in compliance with the requirements of the current GMP, company SOPs and Health and Safety policies/SOPs.

· To support the Head Quality and GMP compliance in ensuring the efficient functioning and implementation of all the Quality related activities at the site.

· Coordinating and functioning as a key participant in customer and regulatory inspections.

· Preparing a response to the regulatory / customer audit/inspection. Monitoring and tracking of audit/inspection CAPA to ensure timely closure and effectiveness of CAPAs.

· Issuance and archival of Change Control, Deviations, CAPA, OOS, and OOT to maintain compliance with GMP standards.

· To investigate the nonconformance by visiting the actual place of non-conformance and gathering the evidence. To write/review an investigation report.

· To track, and monitor the closing of deviation / CAPA/ OOS/OOT in a timely manner.

· To prepare a trend report for CAPA/deviation to identify any adverse trends and to suggest an improvement.

· To review trend reports of OOS/OOT/OOE, EM, Water etc.

· To review Product Quality Review reports.

· To assess the risks associated with systems/failures or changes as per the written procedures.

· To maintain/update the various licenses/product licenses/facility licenses as per the written procedure.

· Review of Validation documents (Cleaning, Manufacturing / Packaging Process, Sanitization & Drainage), facility, equipment & systems (HVAC, Water System, Compressed Air System & Computerized System).

· To ensure environmental monitoring of manufacturing, warehouse, and other controlled areas is done as per the approved schedule.

· To monitor calibration and preventive maintenance activities in warehouse, engineering, and manufacturing departments.

· To be part of a cross-functional self-inspection team to perform self-inspection GMP audits.

· To perform a GEMBA walk at a regular frequency in premises and various functions.

· Undertaking any other duties for any other department within the business, which may be requested by the Head Quality and GMP compliance for which training and/or an explanation has been provided and understood.

· 3-5 years of experience in pharmaceutical GMP in finished dosage forms (OSD, Oral Liquid, Injectables/sterile preparation).

· Experience in MHRA and USFDA approved facility is desirable