Greetings from the Apnar Pharma.
We have requirement in Regulatory Affairs & QA Department.
1) Regulatory affairs
Designation Level: Officer/Executive
Experience Required: 2 to 5 years
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Education B. Pharm / M. Pharm
Job Location: Vadodara, Gujarat
1. For CMC reviewer and compilation -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)
-Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report..
-Have ability to co-ordinate with cross functional team -Having experience for Drug listing and annual updates -Having ability to review documents as per current regulatory guidelines.
– Have experience of compilation of Labelling section of US ANDA/EU MA
-Preparation and review of artwork related to ANDA in line with innovator product
-Maintain product life cycle for Labelling requirement in line with RLD updates
-Submission of labelling SPL through software as per regulatory requirements
If you know the suitable candidates, Please inform them to forward their updated Resume on firstname.lastname@example.org
2) REQUIREMENT IN QA DEPARTMENT.
Education: B.Pharm / M.Pharm /M.sc
Experience: 5 to 7 years in ANALYTICAL QUALITY ASSURANCE (QA in QC)
Position level : Executive/Sr. Executive
Job Description :
1. The candidate should have experience of Analytical quality assurance with Good knowledge of GLP. 2. Having experience for Handling of QMS activity
(OOS, Deviation, Lab incident, change control) related to Quality control.
3. To ensure Good laboratory practices to be followed in QC laboratory
4. Review of QC/ADL documents like Calibration documents, Specification, STP, Certificate of Analysis, Method validation and Method verifications.
5. Additionally review of Microbiological documents.
If you know the suitable candidates, Please inform them to forward their updated Resume on
Thanks & Regards,
Manager – HR
Apnar Pharma Private Limited