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Opening for Manager Stability Studies (Q.A.) at AKUMS DRUGS & PHARMACEUTICALS

 

Clinical courses

AKUMS DRUGS & PHARMACEUTICALS LTD is one of the most innovative, productive and research based pioneer organization of India having its registered office at Delhi and various plants in Haridwar, Uttrakhand giving employment to more than 2000 people. Akums is engaged in the manufacturing of tablets, capsules, injections, syrups on loan licensing and third party manufacturing basis. Akums is having certifications of WHO-GMP, ISO 9001, ISO14001:2004,NDA Uganda, PPB Kenya and complying USFDA , MHRA & other international standards.

Post: Manager Stability Studies (Q.A.)

Job Description:
1. Planning of Charging Stability studies Samples as per Schedule
2. Timely Charging and withdrawal of sample from stability chambers.
3. Maintaining the Reconciliation Records of samples.
4. Maintaining the temperature and humidity data and monitoring of the stability samples.
5. Review of stability documents for compliance with SOP’s.
6. Review of the analytical records and raw data for accuracy and authenticity.
7. Timely validation of Stability Chambers.
8. Handling of OOS, in the case of failure.
9. Preparation of Summary sheets, stability study protocols etc related to audits like USFDA, MHRA, WHO etc.
10. Online verification of documents and ensuring that the analysis is done as per the CGLP requirements.
11. Exposure in Pharma facilities with WHO-GMP Certification or above.

Candidate Profile:
Essentials:

1. Candidate should be B.Sc/B.Pharma/M.Sc/M.Pharma or suitable qualifications.
2. Min of 5-6 yrs. Exp. in the area of QAD.
3. Computer savvy with excellent interpersonal and communication skills.
Desirables:
1. 3-4 yrs exp in the field of stability studies as per the internalized guide lines.
2. Proficiency in computer is must.

Additional Information:
Exp: 5-8 years
Location:
Haridwar

Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA

Forward your resume at, resume@akums.in

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