Compliance Group is run by a team who are at the cutting edge of developments in Compliance. The team is supporting mid-size and large Life Sciences clients and is actively engaged in discussions with FDA consortiums that set the direction for the Industry. Engaging us will not only ensure your timelines are met but will also result in contributions from our organizational assets.
Post : Quality Assurance - QMS Documentation
Job Description
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.
16. Strong computer skills including Microsoft Office, Knowledge of tools, concepts and methodologies of QA Knowledge of relevant 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 : Min 3 years
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma
Functional Area : Quality Assurance - QMS Documentation Oral solid dosages
Salary: Rs 3,00,000 to 4,20,000 /year
Send your Resume at : srinivasan.kidambi@compliance-g.com
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