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Friday, May 14, 2010

Executive –Regulatory Affairs Leading company in Pharma Industry

Checking and approval of following documents at production site as per requirement for US/MHRA regulatory authority. 

• Specification, Batch manufacturing record, all protocols, all validation documents, SOP’S etc.

Summary

Experience:
3 - 8 Years
Location:
Mumbai
Education:
UG - B.Pharma - Pharmacy,B.Sc - Any SpecializationPG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D
Posted Date:
12 Apr

Desired Candidate Profile



Specific Requirements: -

Knowledge: Code of federal regulations and GMP requirement.

Skills: Expertise in review of documents i.e. IQ, OQ and PQ of equipment, equipment and area cleaning validation, Water system, executed batch record, certificate of analysis of API, excipients and finished product along with chromatograms

 

Job Description

Job Description (Activities to be handled):
• Checking and approval of following documents at production site as per requirement for US/MHRA regulatory authority.

• Specification, Batch manufacturing record, all protocols, all validation documents, SOP’S etc.

• Collation, checking for correctness of batch executed documents and its related documents like analytical documents with its backup data, product stability related documents, tracking record of material and sample etc.

• Providing support to plant regulatory requirement.

• Ensuring that there is no change in the already submitted doc for regulatory filing.

• Coordination with Plant, R&D and corporate regulatory affairs.

 
Keywords: Regulatory affairs

Company Profile

Leading company in Pharma Industry
Contact Details
Company Name:
Leading company in Pharma Industry
Website:
Not Mentioned
Executive Name:
Ms.Gunjan Laherwani
Address:
Not Mentioned
Email Address:

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