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: Team Member - Quality Assurance - 15000272
Job Description:
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:
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Prepare controlled documents; Conduct distribution, retrieval, archival and destruction of controlled documents; Prepare new documents as per cGMP requirement, as and when required
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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
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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
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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
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Prepare and update the vendor list as per the schedule; Initiate the vendor evaluation documents; Maintenance of master data SAP related to vendor
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Prepare the APQR report; Summarize the data collected in APQR preperation; Assist supervisor in preparing recommendations based on APQR evaluation
Candidate Profile
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
- Graduate degree in Pharmacy / Chemistry
- Minimum 1 year of experience in pharma industry
- Application knowledge of Regulatory requirements
- Knowledge of Quality Management System, GMP Requirements
- Knowledge and experience of regulatory audits(USFDA, EUGMP etc)
- Proficiency in speaking, comprehending, reading and writing English is required / preferred
Additional Information:
Experience: min. 1 year
Location: Andhra Pradesh- Vizianagaram
Education: B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 25th Feb., 2015
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