Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
Post: Executive / Asst. Mgr- Quality Assurance-Unit-3-JDM
Job Description:
Areas of Responsibility
The Team Member - Quality Assurance will have the following key responsibilities:
1. Prepare controlled documents; Conduct distribution, retrieval, archival and destruction of controlled documents; Prepare new documents as per cGMP requirement, as and when required
2. Prepare employee training curriculum, annual schedules; Coordinate with internal trainers and execute the training as per schedule; Maintain, check and update the training records; Assess the training evaluation questionnaires; Conclusion of re-training requirements
3. Track and highlight deviations in manufacturing operations to the supervisor; Provide line clearances after satisafactory review;
FDF: Perform in-process sampling as per production schedule
4. Initiate the change control with necessary document support; Execute the approved changes as per the action plan; Prepare the validation protocols and reports; Verify documents with current equipment capability; Execute the validation/ qualification processes at each stage of manufacturing
5. Prepare and update the vendor list as per the schedule; Initiate the vendor evaluation documents; Maintenance of master data SAP related to vendor
6. Prepare the APQR report; Summarize the data collected in APQR preperation; Assist supervisor in preparing recommendations based on APQR evaluation
Candidate Profile:
Education:
Graduate degree in Pharmacy/ Chemistry
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Experience:
Minimum 1 year of experience in pharma industry
Competencies:
- Application knowledge of Regulatory requirements;
- Qualifications and Validations
- Knowledge of Quality Management System
- Knowledge of GMP Requirements
- Knowledge and experience of regulatory audits(USFDA, EUGMP etc)
Additional Information:
Experience: Minimum 1 year
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 30th June, 2013
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