Technical / Functional :

Job Objective :

To perform the QA activities in view of system upgradation and improvement in the existing procedures.

Job Role:

• 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events.
• 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable.
• 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors.
• 4. Preparation & review of quality risk assessment reports of products & general systems.
• 5. Conduct on the Job Training and cGMP trainings.
• 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records.
• 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification.
• 8. Co-ordination with the customer for compliance and day to day issues.
• 9. Quality agreements review and preparation.

Desired attributes :

Technical / Functional :

• Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance).
• Should have sound command on the English with speaking and Writing.
• Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions.

Behavioral :

Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

Undertaking any other duties which may be assigned as deemed appropriate by the organization