Saga Lifesciences Ltd Job Vacancy for Regulatory Affairs/ Production Department
We have urgent requirement of Production Officer having 1 to 3 years experience in Granulation/Compression area of Pharma Formulation company.
Experience: 1 to 3 years
Qualification: B.Sc, M.Sc / B.Pharma ,M.Pharma
Location: Ahmedbad, Gujarat
Salary depends on experience and personal interview.
Job Description
1. Approval in tablet & capsules most preferred.
2. Knowledge of granulation, compression & coating.
3. BRM, CGMP Practices.
4. Audit knowledge of GMP, MHRA & EU
5. Shifting scheduling, Batch
Manufacturing, line clearness, production planning.
6. Materials management(RM & PM) both
7. Manpower planning and allocations.
8. (Knowledge of Tablet Capsule, Coating, Compression, Granulation,)
9. Issue of Batch from quarantine area for compression, coating, capsule and Granulation.
10. Carry out in process parameter checking activity during compression, coating, capsule and Granulation activity.
11. Allocation of work to operator and helpers.
12. Performing production activities as per daily production plan.
13. Ensure environmental condition and pressure differential in production area.
14. Ensure all SOP’s of respective equipment are followed during production.
15. Transfer of production Batch to quarantine area and completion and reconciliation of Batch.
Interested candidates can apply on hr@sagalifesciences.com
2) We have urgent requirement of RA Officer having 1 to 4 years experience in RA department.
Post: Regulatory Affairs – officer/ Executive
Experiences: 1 to 4 years
Qualification: B.Sc,M.Sc, B.Pharma,M.Pharma
Salary: Depend on Personal Interview
Location: Prahaladnagar, Ahmedbad
Job Description
Regulatory Affairs – officer
1. Prepare & compile registration dossier of ACTD, CTD & Regional as per the guidelines and checklist for submission to Regulatory authorities.
2. Co- ordinate with various departments to obtain essential documents required to send query responses & review and compile error free responses to query letters.
3. Must have knowledge regarding Analytical Method validation preparation and review
4. Distribution and Execution of the regulatory work plans.
5. Artwork checking as per country guideline
6. FDCA work (COPP, FSC, product permission) & CDSCO Sugam application
Interested candidates can apply on hr@sagalifesciences.com
Regards,
Saga Lifesciences Ltd
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