Overview
AGM- Quality Assurance Jobs in Bangalore, Karnataka, India at Rubicon Research Limited
Job Title:
Assistant General Manager
Department:
Quality Assurance
Location:
Ambernath
Years of
Experience:
16+ Years
Dosage Form:
Solid Oral/ Nasal
Job Responsibilities:
– To ensure cGMP Compliance as per laid down procedures.
– Execute and Monitor key QA activities – Process validation, Cleaning Validation, Equipment Qualification, Instrument Qualification, Utility Qualification and Master Document review.
– Preparation and review of SOPs applicable to QA.
– Evaluation of QMS documents.
– Preparation of Validation Master Plan, review of process validation, equipment qualification and cleaning validation protocols and reports
– Participate in investigations and review of investigations.
– Monitoring of Exhibit and Submission batches documentation and Coordination with RA for document submission
– Monitoring of document control, storage, and archival.
– To provide training to QA team members and other functions.
– Participate in customer and regulatory inspections and ensuring CAPA effectiveness.
– Participate in self-inspections. To audit the internal quality system as a part of self-inspection (internal audit).
– Timely and proactively escalating issues.
Qualifications & Pre-Requisites
Must-Have
Skills:
– B. Pharm/ M. Pharm With relevant experience in pharma
quality assurance
.
– Must have knowledge of Process Validation, Cleaning Validation, Equipment Qualification and ability to handle the team.
– Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA.
– Exposure to specific dosage forms like OSD and Nasal.
– Must have shop floor experience and in-process
quality assurance
.
–
Effective communication
, Team coordination and work in
collaboration
within compliance
Title: AGM- Quality Assurance
Company: Rubicon Research Limited
Location: Bangalore, Karnataka, India
Category: Quality Assurance – QA/QC, Healthcare
