Be the First to Apply
Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Senior Research Associate-FD
Job Description
Preparation and/or review of Technology transfer documents and regulatory submission support
- Preparation and/or review of Technology transfer documents and regulatory submission support i.e.Master formula card, Master packaging card, Pre-EB batch records (BMR & BPR), Process qualification and sampling protocol, IPS, FPS, SPS, EB batch records (BMR & BPR), Hold time study protocol, Submission batch monitoring protocol, Stability protocol, development report (Elemental impurity report, Residual solvent report), Pre-Exhibit Batch monitoring report, Exhibit Batch monitoring report, Hold time study report, intended batch records (BMR & BPR) for smooth transfer of product across the globe as well as for regulatory submission.
- Preparation and/or review of technical documents for clinical batches manufacturing within assigned timelines i.e., BMRs and BPRs, for timely completion of GMP batch execution following the GDP.
- Preparation and revision of department relevant standard operating procedures and guidelines and to ensure training of all concern personnel.
- Initiation, approval and timely closure of change controls and deviations to ensure compliance and to identify impact/risk assessment of changes proposed.
- To support in regulatory queries related to drug product submission.
- Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
- Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
- Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
- Completion of assigned activities by management or organization for product development and organization improvement within agreed timelines.
- Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
- Any other responsibility given by manager or organization.
English, Master of Pharmacy (M.Pharm)
