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Friday, January 6, 2012

Formulation Pharmaceutical Technology Scientist by Dr. Reddy's Laboratories Ltd. in Hyderabad / Secunderabad

Job Description
- Establish and meet project time lines (within control)

- Generate development protocols, sampling/testing plans, and technical reports

- Generate manufacturing batch records for experimental, specification, pivotal/stability, and process validation batches

- Execute experimental, specification, and pivotal/stability batches directing scientists and technicians activities in support of this.

- Assist QA Validation in execution and observation of process validation batches

- Provide technical assistance to QA Validation in identifying critical process parameters

- Evaluate data from experimental, specification, and pivotal/stability batches to develop/transfer rugged manufacturing processes

- Apply statistical process control techniques to determine process capability and SPC status

- Provide labor and material requirements to Finance/Contract Sales for quotations to customers for various development activities

- Evaluate potential contract sales opportunities for technical feasibility wrt equipment, facility, and  personnel

- Collaborate with other departments to achieve project goals:  Material Management, Quality Control, Contract Sales, Manufacturing, Maintenance and Engineering, QA Validation, QA Pharmaceutical Product Management

- Write and review department SOPs

- Provide technical support for marketed products to the QA and Manufacturing departments.

- Provide production troubleshooting and manufacturing assistance.

- Initiate and carry out investigations and Corrective Actions/Preventive Actions (CAPA).

- Perform risk assessments and generate product impact evaluations for manufacturing Incident Reports.

- Review GMP documents (MBRs, SOPs, RM specifications, protocols) and generate change controls.

- Perform scale-up and process optimization of marketed products.

- Write and review technical reports
Not Disclosed by Recruiter
Pharma, Biotechnology, Clinical Research
Functional Area:
Engineering Design, R&D
Role Category:
Engineering Design
Senior. Design Engineer
Formulation Process Development PD
Desired Candidate Profile
(UG - B.Tech/B.E. - Chemical) AND (PG - M.Pharma - Pharmacy, M.Tech - Chemical)
 - Minimum of 5 years experience in Pharmaceutical industry

- Minimum of 3 years experience in Pharmaceutical product and/or process development or production technical support

- Continued education in pharmaceutical science (formulation, process equipment, test equipment, specific dosage form technology)

- Experience in solid-dosage manufacturing unit operations: granulation, drying, milling, blending, tablet compression, pan coating, fluidized bed processing, tablet printing, encapsulation.

- Experience in tablet formulation, process development, scale-up, technology transfer, manufacturing trouble-shooting, failure investigations.

- Experience in data analysis, technical report writing, Root Cause Analysis, Risk Assessment.

- Knowledge of pharmaceutical GMPs and regulatory requirements. <>


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