Assistant Manager CQA | API | USV | Mumbai

Job Description

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
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

Location