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
Audits:
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
