Manufacturing Line Leader - DPI
- Organize and oversee the activities related to the manufacturing of DPI (Dry Powder Inhaler) to include delivery of in-process samples in a defined schedule.
- Review and compile the documents generated during the production ofDPI productssuch as Batch Manufacturing Record (BMR), PQprotocols.
- Makeequipmentpart list required formachine, and support supervisor to order it.
- Assign work to operators according to product schedule.
- Make sure to transfer request of product material batches from warehouse to Manufacturing and vice versa.
- Ensure attendance of operators in shift and adherence to shift schedule.
- Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing operations.
- Review batch record after finishing each step for correctness.
- Provide support to the operators inregardingday-to-day production activities such as trouble shooting and other work tasks.
- Assistsupervisor in investigation of deviations and closure of CAPA's.
- Schedule cleaning validation with request asrequiredfor equipment.
- Support supervisor as neededtoday-to-day activity to achieve productivity and compliance.
- Coordinate to implementation of current good manufacturing practices (cGMP) and safety practices in the operations and manufacturing of products.
- Ensure tomaintaina cleanlinessworking environment.
- Ensure EHS compliance. Use ofappropriate PPEas per activity.
- Work closely with Manufacturing Supervisor for Driving operational excellence and flawless executionin order toachieve site quality and manufacturingobjectives.
- Maintaining 100% cGMP and SOP Compliance during complete operation hours.
- Complywithall company policies and procedures.
- Reporting all issues thatariseto the department head or reporting manager.
- Performing daily maintenance on equipment and machinery.
- Completing all documentationin a timely manner, ensuring their integrity,accuracyand completeness.
- May berequiredtoassistin the training of other employees in the department.
- High School Diploma (or equivalent).
- Minimum of1-yearsupervisory experiencerequired.
- An AssociateorBachelor'sdegree in Pharmaceutical Engineering, PharmaceuticalSciencesor related field of study from an accredited College/University is preferred.
- Minimum one (3) year of manufacturing experiencerequired.
- Understanding granulation, compression, coating, and encapsulation machines.
- Capable of conducting troubleshooting, investigations, and root cause identification and analysis.
- Able to prioritize, plan and work under tight schedules and deadlines.
- Mustpossessstrong documentation and technical writing skills.
- Must be able to clearly communicate in English (verbal and written).
- Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment.
- Basic understanding of mechanical machinery and the operating principles of control systems.
- Demonstrated ability to work independently and in team environments.
- Good knowledge of Health and Safety procedures including OSHA
- Strong mathematical and organizational skillsare important.
- Basicproficiencyin computer skills and software applications such as Microsoft Office tools.
- Experience using SAP businesssystemsand applications is a plus.
- Frequently lift, bend, and carry up to 35 lbs. throughout the shift.
- Stand or walk for extended periods; climb ladders as needed.
- Use pallet jacks to move up to 200-300kg of equipment and materials.
- May berequiredto wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance -medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits. About Cipla Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus byconsolidatingand deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose of 'Caring for Life',Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla hasemergedas one of the most respected pharmaceutical names in India as well as across more than 100 countries.Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy.Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States. Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. About the Salary/ Pay Range The salary range mentioned above isan anticipatedbase salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
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