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: QA Sr. Manager
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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Establishing adequate measurements to monitor areas performance and participating in the control and auditing of manufacturing and packaging operations to assure conformance of products.
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Managing the Quality Assurance areas and staff to achieve effective and efficient operations and communicating control policies, CGMP regulations and requirements to Quality Assurance, manufacturing and packaging personnel
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Conducting audits of Manufacturing and Packaging Records and QA process related documents to assure that documentation is free of errors and complies with GMP’s and SOP’s.
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Representing the Quality Assurance Department, in the absence of the QA Director during regulatory in-plant inspections
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Initiating or revising department SOP’s in order to comply with quality standards. Reviewing and approving company SOP’s as required; Reviewing existing control/manufacturing operations and provides innovation of more effective/efficient techniques
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Ensuring that Quality Assurance area goals and objectives can be accomplished in a timely manner; Providing a positive, highly professional environment that can promote open communication, creativity and continuous improvement attitudes; Enforcing safety rules and attitudes to promote a healthy environment
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Selecting, training and evaluating the performance of personnel. Recommending compensation changes in a timely manner. Planning and providing developmental opportunities for personnel in both technical and management areas to increase productivity and encourage job satisfaction
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Reviewing and approving Quality Assurance and production investigation reports as required. Evaluating investigation reports and all related documentation for compliance with GMP’s, SOP’s and pharmaceutical regulations
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 qualifications for this position:
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Minimum of a Bachelor's degree in Science or equivalent
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2-4 years of experience in a management or supervisory position (a combination of experience and/or education will be taken into consideration)
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Must possess in-depth knowledge of the entire manufacturing/ packaging processes and pharmaceutical industry
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Must possess extensive knowledge and interpretation of established standard operating procedures and the current Good Manufacturing Practices, FDA, MHRA and other pharmaceutical related regulatory agencies
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Plan, coordinate and audit all the phases of the Quality Assurance personnel functions in support of overall plant business objectives
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Excellent communication and Writing Skills (Spanish and English)
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Must have good working relationship with co-Workers and Management personnel and strong supervisory and leadership skills
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Ability to write, review and maintain QA Standard Operating Procedures and other related documents
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Good organizational skills for tracking and reporting duties are also required in addition to basic computer skills.
Additional Information:
Experience: 2-4 year
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 30th Sep, 2013
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