2 Opening(s)
2.0 Year(s) To 7.0 Year(s)
3.00 LPA TO 7.00 LPA
Key Responsibilities:
Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations.
Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance.
Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals.
Ensure dossiers and product ...
1 Opening(s)
4.0 Year(s) To 5.0 Year(s)
Not Disclosed by Recruiter
Job Description:
We are hiring an experienced QC professional to lead and manage quality control operations in our API manufacturing unit. The Assistant Manager will be responsible for supervising analytical activities, ensuring regulatory compliance, handling audits, and supporting continuous improvement initiatives.
Key Responsibilities:
Supervise routine analysis of raw materials, intermediates, and finished APIs
Review ...
1 Opening(s)
0.5 Year(s) To 2.0 Year(s)
1.44 LPA TO 2.50 LPA
Documentation & Compliance:
Maintain accurate and complete laboratory records in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Prepare and review Certificates of Analysis (CoAs), test reports, and deviation reports.
Ensure compliance with company SOPs, safety protocols, and regulatory requirements (e.g., FDA, EPA, ISO).
Process Validation & Improvement:
Participate in validation of ...
1 Opening(s)
8.0 Year(s) To 10.0 Year(s)
8.00 LPA TO 10.00 LPA
Project Leadership: Lead the overall project, including design, erection, commissioning, and providing engineering support during commercial production. Regulatory Compliance: Obtain necessary permits from local bodies (GIDC, GPCB) and ensure compliance during the project and commissioning phases. Project Planning: Develop detailed project plans and execute design standards in alignment with ...
1 Opening(s)
1.0 Year(s) To 2.0 Year(s)
1.20 LPA TO 2.16 LPA
Must Have
Environment/Pathogen Monitoring Program, Sampling & Testing of Pkg. material, raw material, finished goods, EMP sample
preparation and sterilization microbiological media, Tracking, Weekly Biological indicator test for Autoclave, growth promotion test
Should be aware of ISO & USP guideline for Microbiology. Good knowledge of GMP practices
Educational & Experience Criteria
B.Sc./M.Sc. In Microbiology
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
3.00 LPA TO 5.00 LPA
Environment/Pathogen Monitoring Program, Sampling & Testing of Pkg. material, raw material, finished goods, EMP sample
preparation and sterilization microbiological media, Tracking, Weekly Biological indicator test for Autoclave, growth promotion test
Should be aware of ISO & USP guideline for Microbiology. Good knowledge of GMP practices
Responsible for Decontamination of Bio-hazard waste generated from ...