AR&D- Formulation, (Group Leaders & Team Members)
B.Pharma – Pharmacy,B.Sc – Chemistry
Experience 2 – 6 Years
• Should have a good understanding of working of the AR&D equipments.
• Should be able to analyze the data generated during process development and interpret them.
• Should be well aware of the SOPs, GMP and the safety norms to be followed in the labs.
• Should be good at interpersonal and leadership skills.
• Should be able to manage the performance of his team well.
• He should have good communication skills.
Job Description
• Review the relevant literature and finalize the design of experiments.
• Plan and allocate work to the AR&D team members to ensure timely product delivery.
• Ensure compatibility between API and excipients.
• Ensure compliance to Project management process, Quality systems and regulatory requirement by AR&D team members.
• Carry out Method development and Regular Analysis.
• Review method development and validation reports.
• Interpret analytical data.
• Provide necessary support to the team members for risk assessment and mitigation.
• Prepare the specification documents & COAs( certificate of analysis)
• Prepare the reports after conducting various studies (like stability study and bioequivalence study) at every stage of the formulations development.
• Ensure proper compilation of results from pivotal studies, to be sent to the regulatory authority.
• Prepare the master calibration schedule of the various instruments and ensure that it is followed properly in the lab.
• Prepare guidelines and SOPs as and when required and ensure that the team members work according to the SOPs, GMP and GLP.
• Ensure proper coordination with the team members from R&D department.
• Ensure the availability of chemicals, equipments and accessories.
• Train the team members in specific areas.
Location Hyderabad / Secunderabad
Contact
Srinivas / R Varadarajan
Polaris Management services pvt ltd
2B, Sri Krishna Kaushikam,
2-2-647/287/12, Srinivasanagar Colony,
Baghamberpet
HYDERABAD – 500013
Tel: 040-27403495
Email polarisindia@gmail.com
Posted under Engineering Jobs, Hyderabad Jobs, Jobs By Category, Jobs by Location, Pharmaceuticals, Secunderabad Jobs
This post was written by admin on May 31, 2010
