What are the responsibilities and job description for the Manager Quality Assurance position at abbott?
JOB DESCRIPTION: Minimum Qualification: M. Pharma/ B. Pharma/M.Sc. Candiate shall be well versed with manufacturing and packaging operations, Compression Machines, Isolators, Blenders, Bulk packing lines, & Process Validation. Followings will be the responsibilities of the position holder: To ensure compliance of current Good Manufacturing Practices in the Hormone facility & to follow GDP with data-integrity compliance. Preparation, and review of qualification and Validation documents (URS, DQ, IQ, OQ, PQ etc.) for Hormone facility. Preparation, review and approval of process validation and cleaning validation protocols for Hormone facility. Management of control sample Preparation, updating, review and approval of Validation Master Plan, Site Master File, Quality Manual for Hormone facility. Co – ordination with other departments for streamlining qualification, validation, IPQA and QMS activities for Hormone facility. Handling of QMS activities (Change Control, Exceptions, CAPA, Market complaints) for Hormone Facility. Batch release – Responsible for review of the executed batch documents and release of finished product for Hormone Facility. To ensure effective working of In-process Quality Assurance activities including ensuring calibration of IPQA instruments as per schedule for Hormone Facility. Preparation and review of APQR. To review and approve batch records of Hormone Facility. To conduct self-inspection/ internal audit as per site Internal Audit Program. To investigate and provide CAPA for self-inspection/ internal audit and external audit observation. Co-ordination with Service providers for the qualification / validation activities. Qualification of service providers for Hormone Facility. Review of Calibration and Preventive Maintenance related documents. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: EPD Established Pharma LOCATION: India > Village Mauza : Baddi ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter