Casper Pharma Pvt. Ltd - Urgent Openings for Regulatory Affairs / Quality Assurance - Apply Now - PHARMA WISDOM

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Sunday, 24 May 2020

Casper Pharma Pvt. Ltd - Urgent Openings for Regulatory Affairs / Quality Assurance - Apply Now


Executive / Senior Executive - Regulatory Affairs / RA USA Formulation @ CASPER PHARMA PVT LTD
Job description:
B. Pharma / M.Pharma with 2 to 6 years relevant formulation experience in Regulatory Affairs for US submission with following experience:
1.     Author high-quality CMC documentation for US FDA submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
2.     Prepare CMC responses to US FDA questions during development, registration and product lifecycle.
3.     Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4.     Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
5.     Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Actively participate as a member by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
Senior Manager / AGM - Formulation Quality Assurance
Job description:
B Pharma / M Pharma with 14 to 18 years relevant Formulation Quality Assurance experience with following expertise required.
1. Shall be responsible for oral Quality management system
2. Handing of site Quality operations includes engineering assurance ,mfg assurance and warehouse systems
3. Oral inchage of GLP at QC and Microbiology lab.
4. Heading of Qualifications and Validations of plant
5. Leadership role to drive the Quality culture and businesses gole.
Interested Candidates Send CV to planthr@casperpharmaindia.com


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