Job Description
● Review and approve all SOPs before finalization.
● Review and approve all protocols before finalization.
● Review and approve master BMR, BPR, and BCR content.
● Conduct and ensure proper document control procedures.
● Ensure proper pest control activities in the facility.
● Ensure proper and efficient training practices for all GMP-related personnel.
● Ensure proper and efficient medical check-ups for all GMP-related personnel.
● Establish an appropriate QMS system and ensure proper QMS practices as per SOPs (NOE, deviation, CAPA, investigation, OOS, and OOT).
● Ensure proper investigation and follow-up of regulatory-related issues such as complaint, return, and recall.
● Conduct correct training programs.
● Establish QRM in the facility.
● Quality policy and manual preparation/review.
● VMP and SMF preparation/review/approval.
● Ensure correct and effective in-process quality assurance.
● Plan and conduct self-inspections.
● Plan and conduct equipment qualification activities.
● Conduct and ensure effective validation activities.
● Plan and conduct vendor qualifications.
● Ensure reliable outsourcing activities.
● Collaborate in technology transfer activities.
● Collaborate in artwork preparation.
● Conduct PQR activities.
● Ensure good manufacturing practices in production and packaging.
● Ensure good storage practices.
● Ensure good documentation practices in facilities.
● Ensure good engineering practices.
● Ensure good laboratory practices.
● Conduct GMP audits by regulatory bodies.
● Ensure GXP issues in contract manufacturing.
● Collaborate in any activities related to QA for systems startup and continues operation.
● Do any other activities assigned by Quality Head and managing director time by time.
