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Category: Medical/Pharma

Deputy General Manager - Analytical Development

Renata Limited

Vacancy

01

Job Responsibilities
  • 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.
Employment Status

Contractual

Educational Requirements
  • M.Sc with B.Sc in Chemistry
Experience Requirements
  • 14 to 18 year(s)
Additional Requirements
  • Age 35 to 45 years
  • 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.
Job Location

Dhaka (Mirpur)

Salary
    Negotiable
Job Summary

Published on: Jan 6, 2020

Vacancy:  01

Employment Status: Contractual

Experience: 14 to 18 year(s)

Age: Age 35 to 45 years

Job Location: Dhaka (Mirpur)

Salary: Negotiable

Application Deadline: Jan 20, 2020

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(রিপোর্ট)
এই চাকরির জন্য বিজ্ঞাপন দাতা প্রতিষ্ঠান আপনার কাছ থেকে কোন অর্থ চাইলে অথবা কোন ধরনের ভুল বা বিভ্রান্তিকর তথ্য দিলে অতি সত্ত্বর আমাদেরকে জানান অথবা জবটি রিপোর্ট করুন

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Application Deadline : January 20, 2020
Company Information
Renata Limited Address : Plot #1, Milk Vita Road, Section-7, Mirpur, Dhaka-1216 Web : www.renata-ltd.com Business : Renata Limited (formerly Pfizer (Bangladesh) Limited) is one of the leading pharmaceutical companies in Bangladesh. Its vision is to establish itself permanently among the best of innovative branded generic companies.