Technical Expert Derma

  • Hyderabad, Visakhapatnam
  • 10-15 lakh
  • 3-8 years
  • 29 May 2015

  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Review the literature and coordinate with IPM
Prioritize development of the formulation depending on urgency
Look at the patent landscape and the manufacturability of the product
Finalize the synthetic scheme of experiments
Plan and allocate resource as per project priorities within the team and assess the cost impact
Ensure compatibility between API and excipients
Review input document/interim reports
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 regulatory authority
Prepare specifications for the raw materials and finished goods
Prepares the 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 Analytical R&D department
Provide necessary support to the team members for risk assessment and mitigation
Train the team members in specific areas
Ensure proper maintenance of Lab notebooks

Should have a good understanding of working of the R&D equipments
Should be able to analyze the data generated during process development and interpret them
He 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
Interact with PDT members, COEs and Regulatory Authority

Competencies/Skill sets for this job

Materials Sops Regulatory Authority Gmp Formulations Synthetic

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