Job Responsibilities :
  • To Execute Analytical Method Development activities of drug products under
  • development, based on QbD principles and regulatory requirements.
  • Execution of Analytical Method validation activities for drug products as per the
  • regulatory requirements.
  • Execute routine Analytical Research activities of drug products.
  • Establishing In-house systems and procedures to ensure cGLP practices &
  • regulatory requirements for analytical activities at in-house R & D Facilities.
  • Profile Description & Ability:
  • Strong conceptual, analytical development and validation skills.
  • Good communication (verbal, writing) and presentation skills.
  • Must have ability to work under pressure, meet deadlines, and work on multiple
  • projects simultaneously.
  • Must be a team player and be able to interact with staff at all levels of the
  • company and with external parties as well.
  • Must have ability to work independently.
  • Adequate Job knowledge and exposure to different Analytical methods and
  • instrumentations.
  • Adequate Job knowledge and exposure to QbD, DoE and statistical
  • interpretation etc.,
  • Trouble shooting related to Testing methods, Stability studies, test results and
  • designing of additional
  • experimentations as necessary
  • Execution & coordination for Analytical method transfer activities of drug
  • products.
  • Calibration of the Analytical instruments as per the master calibration schedule.
  • Technical assessment & Analysis of drug substances (API) for projects execution.
  • Review & clearance of technical documents leading to dossier batches
  • executions and registrations.
  • Preparation and review of Specifications, Method of analysis procedures and
  • Analytical development
  • reports.
  • Preparation and review of analytical protocols and reports (Analytical method
  • validation, Method
  • feasibility, Analytical method transfer, etc.).
  • Technical assessments of projects (Screening, pipeline and development projects
  • stages) & Literature
  • search).
  • Preparation of analytical technical documents for dossier / Technology transfer
  • executions / Regulatory
  • submissions of projects.
  • Assisting and resolving technical queries raised during Technology transfer
  • activities & regulatory .
  • submissions.
  • Assisting in establishment of In-house Infrastructure (Analytical equipment's
  • Qualifications and preparation of SOP's).
  • Assessment & coordination on regulatory deficiencies.
  • Assisting with analytical requirements in finalization of project costings.
Educational Requirements :
  • Master of Pharmacy (M.Pharm)
  • The candidate should be an M.Pharm / B.Pharm with a thesis in relevant R&D work.
Experience Requirements :
  • 5 to 7 year(s)
  • The applicants should have experience in the following area(s): Pharmaceuticals, Pharmacist
Additional Requirements :
  • Age 25 to 35 years
  • Both males and females are allowed to apply
  • Candidates who are applying for the senior officer post should have working experience as officer at least 03 years.
  • Candidates who are applying for the Assistant Manager post should have working experience as senior officer at least 03 years.
Compensation & Other Benefits :
  • Salary Review: Yearly
How to Apply
Primary Information
Published on:

Vacancy:

Not specific

Employment Status:

Full-time

Gender:

Not specific

Age:

Age 25 to 35 years

Job Location:

Bogura

Salary:

Negotiable

Application Deadline: