Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
Post: Officer - Quality Assurance - UNIT-3 - 14002717
Job Description:
Make a Difference
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 and distribute, retrieve, archive and destruct controlled documents. Support for DMF/ANDA filing and regulatory queries and prepare new documents as per cGMP requirement, as and when required.
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Prepare employee training curriculum, annual schedules and coordinate with internal trainers and execute the training as per schedule. Maintain, check and update the training records. Assess the training evaluation questionnaires and conclusion of re-training requirements.
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Track and highlight deviations in manufacturing operations to the supervisor and provide line clearances after satisfactory review. FDF: Perform in-process sampling as per production schedule.
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Initiate the change control with necessary document support and execute the approved changes as per the action plan. Prepare the validation protocols and reports and 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 and initiate the vendor evaluation documents. Maintain master data SAP related to vendor.
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Prepare the APQR report and summarize the data collected in APQR preparation, as well as assist the supervisor in preparing recommendations based on APQR evaluation.
Qualifications
Make Our Values Your Values
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 for this position:
- Graduate degree in Pharmacy/ Chemistry
- Minimum 4 years of experience in pharma industry
- 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: Min. 4 year
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 30th August, 2014
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