Global CAPA Effectiveness Leader
3 days ago
: Manager - CAPA Effectiveness
Function:
Quality Management and Compliance
Responsibilities:
To conduct CAPA effectiveness review activities at manufacturing sites of Sun Pharma as per the review plan.
To perform CAPA effectiveness review for CAPAs provided to Regulatory Authorities.
To review implementation status of 'Global CAPA' across Sun manufacturing sites.
To inform CAPA effectiveness review outcome to Lead/HOD and prepare CAPA effectiveness review report within stipulated timeline.
To participate in Regulatory Audit Review activities of manufacturing sites of Sun Pharma, need basis.
Skill Requirements:
A sound knowledge of current regulatory requirements/expectations is essential.
Effective interpersonal, communication, and organizational skills are necessary.
The ability to participate and support project work as allocated by reporting authority is required.
Qualifications and Experience:
B. Pharma or M. Pharma qualification is preferred.
12-15 years of experience in a QA background with knowledge of QMS or compliance is required.
US FDA experience is mandatory.
OSD and Sterile experience is also required, with preference given to those with Sterile experience.
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