Officer - QMS (API)

Role & responsibilities

• To Manage deviation, CCP, CAPA, action items in track wise software.
• To Draft, review, and update Engineering Standard Operating Procedures (SOPs), preventive maintenance checklists, and equipment history cards.
• Validation, Integrity test, Particle count, recovery test of clean room area, Preventive maintenance as per checklist and schedule, filter cleaning records, change control, revises and review SOPs, Qualification DQ,IQ,OQ,PQ etc.
• Maintain and review calibration logs, master instruments lists, and breakdown history logs.
• To ensure Preventive maintenance & filter cleaning of HVAC are carried out as per schedule.
• Work permit process follow up before starting and hand over the work.