Job Title: Manufacturing Line Lead

FLSA Classification: Full-Time, Non-Exempt/Hourly Professional

Work Location: Fall River, MA

Work Hours: First Shift: 7AM - 4PM; Second Shift: 3PM - 12AM; Third Shift: 11PM - 8AM

Reports To: Fall River Operations Manager

Purpose:

The purpose of this role is to assist in manufacturing metered dose inhalation (MDI) products in a pharmaceutical manufacturing company.

Manufacturing Line Lead:

(Requirement:3-10 years of MFG Experience or Management Approval)

Scope

The Manufacturing Line Leader position is a group contributor role and reporting to Supervisor or Manager of Manufacturing Operations at InvaGen/Cipla Fall River.The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent is to give a general scope of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position and provide basic performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role.

Essential Duties and Responsibilities

The job duties for this position include but are not limited to the following:

• Organize and oversee the activities related to the manufacturing of MDI's (Metered Dose Inhaler) to include delivery of in-process samples in a defined schedule.
• Review and compile the documents generated during the production of MDIs such as Batch Manufacturing Record (BMR), PQ protocols.
• Make equipment part list required for machine, 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 in regarding day-to-day production activities such as trouble shooting and other work tasks.
• Assist supervisor in investigation of deviations and closure of CAPA's.
• Schedule cleaning validation with request as required for equipment.
• Support supervisor as needed to day-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 to maintain cleanliness working environment.
• Ensure EHS compliance. Use of appropriate PPE as per activity.
• Work closely with Manufacturing Supervisor for Driving operational excellence and flawless execution in order to achieve site quality and manufacturing objectives.

Other Responsibilities:

• Maintaining 100% cGMP and SOP Compliance during complete operation hours.
• Complying with all company policies and procedures.
• Reporting all issues that arises to the department head or reporting manager.
• Performing daily maintenance on equipment and machinery.
• Completing all documentation in a timely manner, ensuring their integrity, accuracy and completeness.
• Maintaining discipline in department.
• May be required to assist in the training of other employees in the department.
• Flexible to work extended hours, to achieve manufacturing schedule when needed.

Training and Safety:

All employees must undergo various training activities at the start of their employment. New trainings and re-trainings will occur periodically. Operators may be required cross-train in all areas of the manufacturing operations. Employees must strictly adhere to all safety, health, and environmental guidelines at all times and ensure that all safety precautions are being taken during handling of machines.

Qualifications:

• High school diploma or equivalent is required.
• Accredited college certificate or university degree is preferred.
• Minimum one (3) year of manufacturing experience with MDI or aerosol products required.
• Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results.
• Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred.
• Basic understanding of mechanical machinery and the operating principles of control systems.
• Ability to follow both verbal and written instructions.
• Demonstrated ability to work in both independent and team environments.
• Good knowledge of Health & Safety procedures, including, OSHA.
• Strong mathematical and organizational skills.

Physical Requirements:

• This position requires the ability to do heavy lifting / bending frequently.
• Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
• Ability to wear appropriate PPE is required.
• Individual may be required to 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.

GLOBAL COMPANY

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 by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is 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. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.