Associate Director - Quality Control

Jubilant Biosys

15 - 20 years

20 - 25 Lacs

nanjangud

Posted:Just now| Platform:

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Skills Required

procurement team management aerospace pharma consulting life sciences manager quality control budgeting customer interaction recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Ensure lab compliance with established procedures and regulatory standards.
Review QC-related documents: SOPs, specifications, methods of analysis, method transfer documents.
Ensure 21 CFR Part 11 compliance for analytical instruments (Ref: 21 CFR 211 Subpart I).
2. Analytical Activities
Oversee stability studies and holding time studies.
Release analytical reports for raw materials, packing materials, intermediates, APIs, and in-process samples.
Provide analytical support and technical clarifications to customers.
3. Investigations & CAPA
Lead investigations into OOT, OOS, incidents, and deviations.
Ensure timely closure and robust implementation of CAPAs to prevent recurrence.
4. Equipment & Infrastructure
Ensure preventive maintenance and calibration of instruments.
Participate in technical discussions for new equipment procurement.
Approve procurement of chemicals, columns, and instrument spares.
5. Regulatory & Customer Interaction
Respond to regulatory/customer queries.
Initiate additional studies for vendor qualification and regulatory/customer needs.
Implement new systems/procedures in line with regulatory guidance.
6. Team Management & Training
Participate in recruitment for QC lab personnel.
Conduct periodic training and evaluation of QC analysts.
Participate in cross-functional investigations (product failures, complaints, deviations).

7. Budgeting & Vendor Management

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