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: Assistant Manager- QA
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 and review controlled documents; Monitor distribution, revision, retrieval, archival and destruction of controlled documents; Support for DMF/ ANDA filing and regulatory queries; Prepare new documents as per cGMP requirement
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Participate and provide inputs in investigations related to OOS/ deviations/ customer complaints/ OOT/ incidences/ return goods/ recalls in collaboration with cross functional team
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Monitor the online compliance activities during manufacturing operations; Provide line clearances after satisfactory review FDF: Plan for in-process sampling as per production schedule
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Monitor the plant activity and prepare necessary documents with respect to change control action plans; Follow up on approved change control procedures to ensure execution is in line with action plan; Prepare validation documents and conduct first level review of the same; Monitor the execution of validation/ qualification processes at each stage of manufacturing
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Compile the vendor evaluation data/ documents; Maintenance of master data SAP related to vendor; Perform audits of shortlisted vendors as per schedule; Conduct first level review of the approved vendor list
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Conduct first level review of the relevant documents (batch production records, analytical raw data, packaging records, label records etc.) related to QA release
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Prepare and review the APQR report; Analyse and summarize the data collected in APQR preparation; Prepare recommendations based on APQR evaluation
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Engage with employees; Direct and guide team on departmental issues; Provide on-job training to team members
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 qualifications for this position:
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Graduate degree in Pharmacy / Chemistry
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Minimum 9 years of experience in pharma industry
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Application knowledge of regulatory requirements;
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Knowledge of qualifications and validations
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Knowledge of Quality tools including root-cause analysis, investigations
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Knowledge of Quality Management System
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Knowledge of cGMP requirements
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Knowledge and experience of regulatory audits (USFDA, EUGMP etc)
Additional Information:
Experience: Min. 9 year
Location: Andhra Pradesh
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 5th Jan, 2014
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