Renata Limited

Deputy General Manager - Analytical Development

General Info
  • Published on: Jan 06, 2020
  • Deadline: Jan 20, 2020
  • Source: bdjobs.com
  • Vacancy: 1
Job Details
  • Job Nature: Contractual
  • Job Level: Unspecified
  • Job Location: Dhaka (Mirpur)
  • Salary: Negotiable
  • Job Description:
    • Establish and carryout departmental goals and procedures.
    • Manage laboratory activities to support product development with laboratory compliance.
    • Planning with team leaders for execution of assigned projects and provide technical supports.
    • Coordinating with vendors/ CROs for new project proposals, technical discussion and resource management for laboratory day to day activity.
    • Coordination with different cross-functional teams to resolve analytical issues.
    • Coordination with product development team to timely support for product development.
    • Review of analytical method development reports, specifications, standard test procedures and standard operation procedures.
    • Review and approval of analytical method validation protocols and reports.
    • Review of the deficiency given by regulatory bodies.
    • Ensure timely support to regulatory affairs for submission of dossiers for registration.
    • Identify places to cut costs and to improve robust, rugged and cost-effective product.
    • Responsible for technology transfer from analytical development laboratory to quality control for commercial manufacturing.
Job Requirements
  • Age Specification: 35 to 45 years
  • Gender Specification: Unspecified
  • Educational Requirements: M.Sc with B.Sc in Chemistry
  • Job Requirements:
    • 14+ years' Experience in a similar position within Industry will be given preference.
    • Analytical: Hands on experience on Analytical Method development by following QBD (DOE) approach, Analytical Method validation/verification, Analytical Method transfer, Stability Studies & trouble shooting.
    • Documentation: Designing specification, Test procedure, Technical report writing for dossier filling, response to regulatory query and quality documents preparation (Justification/SOP/Investigation Reports/Incident/Deviation/CAPA)
    • Technology Transfer: Thorough understanding on Technology Transfer requirement as required by regulatory agency.
    • Audit and Compliance: Have directly handled USFDA, MHRA and other regulatory audits as Analytical method validation SME (Subject Matter Expert)
    • Have a good awareness of cGLP, cGMP and QbD principles through Continuous oral And Visual Training.
    • Have knowledge in regulatory requirements and Quality guidelines as per FDA.
  • Experience Requirements: 14 to 18 year(s)
Apply Procedure
  • Apply Instructions: Photograph must be enclosed with the resume.
  • Apply Link: Apply Online