Work as Executive Quality Assurance Documentation at Pharma Compliance Group | 05 Posts

 

 

We are an end-to-end Global Quality Compliance Services Provider to Pharma, Biotech & Medical Device companies. Compliance Group works closely to help our customers succeed through documented evidence of the fulfilment of qualification, compliance and validation protocols. Our bottom line is helping our customers meet the precise standards of the FDA, EU Annex, and ISO with our experienced and skilled team supported by technology and domain partners.  We are the only Technology/Service Provider representative in FDA Consortium that is comprised of a coalition of large Pharma and FDA agents. As a result, we bring to the table the most up-to-date thinking from the agency, often saving millions of dollars for our customers.

Post : Executive Quality Assurance Documentation

No of posts : 05

Responsibilities and Duties
1. Exposure Quality Assurance in QMS Documentation for Solid Orals Dosage forms
2. Draft quality assurance policies and procedures.
3. Interpret and implement quality assurance standards.
4. Evaluate adequacy of quality assurance standards as per global GMP regulations.
5. Devise department procedures and directions for recording and reporting quality data
6. Review the implementation and efficiency of quality and inspection systems.
7. Relevant experience in handling documentation and reviews of CAPA, Change controls, Deviations, internal audits and other quality assurance activities.
8. Collect and compile statistical quality data as per global GMP regulations.
9. Develop and review Standard procedures of various functional departments.
10. Develop, recommend and monitor corrective and preventive actions and deviations.
11. Prepare reports periodically to communicate outcomes of quality activities.
12. Coordinate and support on-site audits and preparation of GAP analysis reports
13. Evaluate audit findings and implement appropriate corrective actions
14. Responsible for document management systems.
15. Assure ongoing compliance with quality and industry regulatory requirements.

Candidate Profile
1. Bachelors and Masters degree preferred
2. Experience in quality management system documentation
3. Pharmaceutical Industry-specific experience in oral solid dosage form
4. Strong computer skills including Microsoft Office, Knowledge of tools, concepts and methodologies of QA Knowledge of relevant regulatory requirements.

Additional Information
Experience : 2-4 year
Qualification : B.Pharm, M.Pharm
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Rs 3,00,000 to Rs4, 20,000/year
End Date : 30th May, 2019

Send you Resume at : srinivasan.kidambi@compliance-g.com

Posted by
Srinivasan
PHARMA COMPLIANCE GROUP

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