Deputy General Manager - Analytical Development
- Published on: Jan 06, 2020
- Deadline: Jan 20, 2020
- Source: bdjobs.com
- Vacancy: 1
- Job Nature: Contractual
- Job Level: Unspecified
- Job Location: Dhaka (Mirpur)
- Salary: Negotiable
- 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.
- Age Specification: 35 to 45 years
- Gender Specification: Unspecified
- Educational Requirements: M.Sc with B.Sc in Chemistry
- 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 Instructions: Photograph must be enclosed with the resume.
- Apply Link: Apply Online