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