FRD Injectables Executive Sr. Executive AM
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Client : Leading listed pharma company having API intermediates Formulations and Biologics business
Key Responsibilities:
Development of injectable formulations including solutions suspensions lyophilized products and other complex injectables for regulated and semi regulated market.
Conduct preformulation studies excipient compatibility and formulation optimization
Perform lab-scale development scale-up and support pilot/exhibit/validation batches
Support technology transfer to manufacturing and assist during process validation
Prepare review and maintain CTD/DMF documentation for regulated and semi-regulated markets
Address regulatory queries and support deficiency responses
Design and monitor stability studies as per ICH guidelines
Ensure compliance with cGMP ICH USFDA/EMA/WHO requirements
Coordinate with Analytical R&D QA Production and Regulatory Affairs teams
Participate in investigations troubleshooting and continuous improvement initiatives
Required Skills & Experience:
Hands-on experience in injectable formulation development
Knowledge of aseptic processing sterilization methods and container-closure systems
Exposure to regulated (US/EU) and semi-regulated (ROW) markets
Strong documentation analytical and problem-solving skills
Qualification:
(Pharmaceutics) / MSc / PhD
Key Skills
- Campaigns
- Animal Care
- Anti Money Laundering
- Endpoint Security
- ABAP
- KG Teaching
