Executive – QA Documentation

From 3 to 4 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

1. Knowledge and exposure to WHO & Other International Regulatory guidelines, practices and product filing. 2. Expert in QMS documentation 3.Expert in Qualification and Validation 4.Exposure on Audit as member to facing auditors. 5. Preparation and review of validation protocols and reports. 6. Knowledge of Quality control GLPs and Lab coordination. 7. Handling stability studies as per the regulatory requirement. 8. Responsible for calibration and maintenance programs, master documentation, batch documentation etc. 9. To extend the support to Regulatory Affairs in preparing the analytical data as per their requirements for registration of products in different countries. 10. Responsible for coordinating with other departments like stores, QC, Maintenance, purchase department, Process development lab in day to day activity for better operational requirements and to follow the cGMP requirements 11. Responsible to prepare the weekly and monthly reports and act accordingly to fulfil the quality assurance requirements 12.Should have sound knowledge of all QA documentation 13.To ensure that all the records are retained as per the requirement.

Role:QA / QC Executive

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional AreaQuality Assurance

Role CategoryProduction & Manufacturing

Employment Type:Full Time, Permanent


UG:B.Pharma in Pharmacy,B.Sc in Bio-Chemistry

PG:MS/M.Sc(Science) in Bio-Chemistry,M.Pharma in Pharmacy

Company Profile

Finebiotics Pharmaceuticals Ltd

Finebiotics Pharma Ltd. has dedicated state-of-the-art manufacturing facilities forBeta-Lactam Dry powder Injections. The company has been envisioned by visionary groups who have merged together their experience, talents, energies and resources to form a company of enterprise, financial prudence, corporate governance, supreme quality and excellence.The company continues to explore avenues of growth and development through SBU's focusing on the Domestic and Export Markets. Backed by a determined administration, a resolute workforce, state-of-the-art work environment, an effective R&D and F&D department and strong ethical values, the company is poised to take significant strides towards further progress and accomplishment. Finebiotics runs on principles of quality management systems as per EFQM guided by its mission, vision, values and ethics which act as role models. The company ensures Environment Safety, Health and Hazard Risk Management and CSR. The company is moving towards a long term goal of discovery, development, manufacture, marketing and sales of novel drugs.
Company Info
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Contact Company:Finebiotics Pharmaceuticals Ltd