We are currently seeking an Team Leader – Process Development (Injectables) (MS&T) team, specializing in Injectable formulations.
Desired Profile for Process Development :
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) with a specialization in Pharmaceutics or Pharmaceutical Technology.
- 5 – 7 years of experience in process development within the pharmaceutical industry.
- Prior experience in Injectable is essential.
Key Responsibilities:
- To review and provide technical inputs on product development report (PDR), Master formula card (MFC) and Technology transfer (TT) documents etc.
To prepare product process related risk assessment.
To prepare protocols and reports for feasibility trials, scale up batches.
To involve in the Trial / Scale-up / Exhibit Batches.
To prepare and review Exhibit batches Batch manufacturing record (BMR) and Batch packaging record (BPR).
To prepare Scale-up Batches / Exhibit batches summary reports.
To Support Process Validation (PV) batches and provide technical inputs in process validation documents such as Critical Process Parameters (CPPs), Critical Quality Attributes (CQA) and controls.
To support regulatory filing by providing intended commercial batch manufacturing record (BMR), Batch packaging record (BPR) and stability evaluation summary.
To support regulatory in getting Test licence, Import licence, No objection certificate (NOC) and Manufacturing licence by providing the necessary documents related to product and process.
To review and provide Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA) as part of Annual Product Review.
Initiation of New Product Introduction (NPI) procedure for new product manufacturing at manufacturing site.
Interested Candidates can also share their CV at [email protected]
