Roles and Responsibilities :
Regulatory and Compliance:
- Conduct initial review of specifications prepared by plants
- Ensure timely distribution of approved documents to relevant departments
- Conduct initial review of documents like MFR, vendor documents etc.
- Conduct initial review and recommend changes to technology transfer documents & PDR
- Conduct initial review of SOPs of plant QA and R&D (CPRL and Peptides) to ensure adherence to regulatory norms and compliance
- Prepare SOPs for vendor qualification, LIMS, API plants
- Conduct initial review of change controls related to API and recommend changes if any
Documentation( Vendor qualification Management):
- Handle SAP/R3 activities which include creation/ change of material master, QI information of vendors etc.
- Conduct initial Review of vendor qualification documents
- Conduct Initial review of quality agreements with vendors and customers and follow-up for sign off on the same
- Act as an auditee for external audits by hosting auditors.
- Coordinate with respective departments to provide required documents and respond to auditors’ queries
- Initiate CAPA for CQA activities, check audit observation responses for completeness
- Prepare yearly schedule for and conduct/ participate in vendor audits periodically to ensure quality adherence and recommend changes if needed
- Initiate action based on vendor quality score received from the plant.
Learning & Improvement:
- Nominate self for and attend relevant internal/external training
- Take initiatives for self-development and update self on recent developments in own area of work Review processes in own area of work and recommend improvements
- Assist in induction training of new joiners (based on expertise/experience)
Desired Candidate Profile :
- Min. qualification required – M.Sc.
- Min. years of relevant experience required – 8 + Yrs