The job involves the following :
In depth knowledge of cGMP (21 CFR Part 210 & 211)
Provide direction and leadership for QA Dept. to improve their performance and meet divisional and overall Company goals.
A very good understanding of validation / qualification requirements; change management; deviation control and management;
investigations & CAPAs, documentation requirements etc.
Design and implement strategies for capability building and innovation of new services.
Provide management with reports on QA activities and findings
Plan and conduct internal audits, study audits and routine process audits for pre-clinical studies as per cGMP requirements
Host external audits
Ensure timely and effective CAPAs
Write and review SOPs. Proactively focus on quality system improvements
Review study reports
Ensure compliance to GMPs and Companys quality system requirements in the Laboratory
Assist VP / AVP-QA in technical and admin. assignments.
Salary and brand reputation
rganization. Established in 1984 it has an envious track record of serving several market leaders across the globe.
It is a team of 783 professionals comprising 458 scientists in various disciplines such as Chemistry, Pharma, Medicine, Microbiology, Molecular biology and Informatics.
The team is slated to double in next three years.
It is a multi-site organization with more than 300,000 sqft world class laboratory facilities.
cGMP, 21 CFR Part 210 & 211, Quality,CAPA QA,USFDA
10-15 Years of experience in quality assurance in who will be responsible for encouraging the quality systems implementation and its compliance.
Major SKill : cGMP,21 CFR Part 210 & 211,Quality Assurance