Pfizer
Pharma
Scientist-GT&E
Neural analysis suggests this role is
optimal for Senior candidates.
“Scientist - GT&E at Pfizer. Skills: Analytical method transfer strategies, Analytical instruments, Method validation, ICH guideline requirements, cGMP/ cGLP compliance, Injectable formulations, Technology Transfer. Perform analytical method transfer strategies from site to site and PSci to site.. Prepare & execute study protocols/reports for AMTEs”
What You'll Achieve.
improving patients' lives; development and delivery of innovative solutions that enhance the quality of life for patients worldwide; meet the production schedule; ensure commercial supply; uphold quality standards; maintain product quality; control process drift
Industry & Context.
Stratification of data from engineering/EB/PVs for CQA trend analysis; Identifying and implementing potential process improvements
What They're Looking For.
Must Have
M. Pharm/M. Sc with minimum 5 years of pharma experience, Experience in Analytical Development/ validation / Technology Transfer of Injectable formulations to cater regulated markets, essentially experience in Plant Technology Transfer support in Injections including process validation., Understanding of DMAIC methodologies (M1/M2/M3), Trained on Minitab tools
What You'll Do.
Perform analytical method transfer strategies from site to site and PSci to site.
Prepare & execute study protocols/reports for AMTEs
Stratification of data from engineering/EB/PVs for CQA trend analysis.
Reviewing/providing feedback and technical/scientific support on project deliverables
i. e. remediation initiatives
To be able to perform the compilation of methods and its requirements.
Ensure compliance to cGMP/ cGLP
organizations procedures and practices.
Ensure effective safety systems are implemented in the premises.
Partnering with manufacturing to meet the production schedule
ensure commercial supply and uphold quality standards.
Perform & review trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
Identifying and implementing potential process improvements in conjunction with manufacturing operations.
Assisting in documenting changes/updates to manufacturing processes and working with manufacturing
and validation to implement those changes.
How You'll Work.
Team & Collaboration
Partnering with manufacturing; working with manufacturing, engineering, and validation
Full Job Description
**Use Your Power for Purpose** As a Senior Associate, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives. **What You Will Achieve** In this role, you will: * Perform analytical method transfer strategies from site to site and PSci to site. * Prepare & execute study protocols/reports for AMTEs * Stratification of data from engineering/EB/PVs for CQA trend analysis. * Theoretical & practical knowledge on working principle of analytical instruments- FTIR, UV, IR, HPLC, GC with minimum 5 years of relevant experience. * Understanding on the purpose of different method validation parameters and ICH guideline requirements. * Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc. * Theoretical knowledge on titration, LOD and understanding the working principle of DSC and TGA etc., * To be able to perform the compilation of methods and its requirements. * Ensure compliance to cGMP/ cGLP, organizations procedures and practices. * Ensure effective safety systems are implemented in the premises. * Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards. * Perform & review trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. * Identifying and implementing potential process improvements in conjunction with manufacturing operations. * Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering, and validation to implement those changes. **Here Is What You Need** * M. Pharm/M.Sc with minimum 5 years of pharma experience * Experience in Analytical Develop
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