Hiring for General Manager- Engineering in Ahmedabad, for Exp. 15 - 22 yrs at Claris Injectables Pvt Limited.

  • Esteemed client of Orion TrueTech Services India
  • Ahmedabad, Gujarat, India
  • May 20, 2018
Full time Pharma, Healthcare & Biotechnology Jobs

Job Description

Job Description:About us&amp amp nbsp Baxter: Baxter International Inc. (NYSE:BAX) is a global healthcare company that assists health care professionals and their patients with the treatment of complex medical conditions. The Company, which is headquartered in Deerfield, Illinois, provides a portfolio of essential renal and hospital products including: home, acute and in-center dialysis sterile IV solutions infusion systems and devices parenteral nutrition and pharmacy automation, software and services. The Companys global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. With 2016 sales of $10.2 billion, and approximately 45,000 employees in the United States, Europe, Asia and Latin America, Baxter is a global leader in developing innovative medical therapies that improve the quality of life for people around the world. Claris: Claris Injectables, based in Ahmedabad, India, is a global generic injectables pharmaceutical company with a successful 15-year history. It has proven capabilities in production of essential generic injectable medicines, such as anesthesia and analgesics, renal, anti-infectives and critical care in a variety of presentations including bags, vials and ampoules. The Company has a robust pipeline and marketed portfolio of generic injectables along with fully integrated research and development expertise and three world-class manufacturing facilities registered with a number of global regulatory agencies, including the U.S. Food &amp amp amp Drug Administration (FDA). &amp amp nbsp Baxter acquired Claris in July 2017 to serve as a foundational asset to accelerate Baxters strategy of becoming a global leader in that market.&amp amp nbsp Why Baxter?A Career That Matters.Baxters employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day. Position Name: &amp amp nbsp General Manager Engineering Business Unit: Manufacturing Facility, Ahmedabad Business Entity: Claris Injectables Pvt Limited (a 100% wholly owned subsidiary of Baxter International Inc.)&amp amp nbsp Purpose of the Role: To be responsible to Formulate, submit for approval, execute and evaluate validation protocols, capability studies and engineering tests for all new or renovated production and process equipment and facilities within Singapore Manufacturing. To be responsible to Supervise the operation of plant utility systems and provide technical expertise to maintain these systems and the major production equipment throughout the plant facility. To Operate an effective, GMP-compliant maintenance function, minimizing equipment downtime to the extent possible while ensuring system and equipment quality specifications are consistently met. To Serve as the lead for installing new or upgraded production and plant utility equipment and ensuring the associated maintenance requirements are established and performed. To Provide training and oversight to department staff in order to execute and document responsibilities in a complete manner per SOP requirements. To Provide investigation support to QMS events with respect to the required analysis for technical, plant utilities, and cleanroom facilities. To Maintain inspection readiness for facility, plant utilities and systems at all times. To Drive implementation of company -wide improvement projects for achieving enhanced and sustainable GMP site wide compliance with manufacturing equipment and plant utilities. To Track and ensure completion of regulatory commitments associated with Technical and Utility department projects or operations. To Maintain complete and accurate departmental SOPs at all times. Ensure all required department tasks and responsibilities are addressed and resolved. To Perform technology upgrades for older machines, systems to comply with the newer regulations, audit findings, and GMPs. To Ensure consistent, quality utility output and continuous monitoring in support of sterile manufacturing operations. To Ensure that downtime, periodic sanitization, replacement, etc., are managed adequately to keep up with the peak needs for sustained manufacturing. To Maintain adequate cleanroom facilities (including doors, panels, gaskets, flooring, personnel airlocks, material transfer hatches, classified rooms, etc.), instrumentation, and electrical/mechanical systems while seeking continuous improvement for quality and GMP compliance in support of sterile product manufacturing. To Install and commission new process equipment and systems to improve facility capacity, reduce costs and minimize bottlenecks. To Provide proactive technical expertise in all aspects of technology, facility, utility, and instrumentation in support of business operations. To Support manufacturing operations with adequate facility modifications to improve workflow and enhance compliance. To Escalate BMs to Overall Head Technical and Utility and Quality management in case of critical failure which may compromise purity, efficacy, potency and safety of drug product and track it through the CAPAs. To Lead engineering and technical resources in support of required Site Acceptance Testing (SAT) for new manufacturing equipment or plant utilities for the facility. To Review equipment performance monthly per defined productivity norms. Apply continuous improvements. To Initiate, investigate, show CAPA effectiveness, and bring to closure QMS Records associated with Technical and Utility department operations. Desired Skills &amp amp amp Experience: Overall 15+ years experience in domains like Pharmaceuticals Sterile Formulation in USFDA approved facility. Functional Expertise: Good Knowledge of Global practices with respect to Engineering. Educational Qualification: BE Mechanical/ Electrical Disclaimer: Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.