Company: Alkem Laboratories
Post: Formulation & Development
Experience: 3 to 5 yrs
Qualification: M.Pharmacy
Location: Taloja, Navi-mumbai
Roles and Responsibilities :
- Literature review, patent evaluation, pre-formulation study.
- Innovator/ market sample evaluation, labs scale batches/ trials, optimization batches and reporting all trail details in PDR / LMB.
- Stability study, planning pivotal batches and conducting same in labs and plant.
- Preparation of scale-up batch, process qualification batch documents and conducting same in-plant facility.
- Preparation of documents for regulatory filing as per target market (US/ EU/ AU) for a new product.
- Preparation of tech transfer documentation like change control, new product introduction, master manufacturing formula, bill of material and product development report for the domestic market.
- Preparation and checking of master manufacturing document, MFR, PDR, process validation report, process validation protocol, checking feasibility parameters in the registered specification for the domestic market and conducting optimization and exhibit batches for the domestic market.
- Conducting exhibit batches in the plant according to cGMP.
- Operating and maintaining equipment and instruments as per SOP.
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