Manufacturing Supervisor MDI

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Ciplas U.S. Subsidiaries or Affiliates.

Job Title: Manufacturing Supervisor - MDI

FLSA Classification: Professional Exempt

Work Location:Fall River MA

Work Hours: General: 8:30AM 5:00 PM (may vary based on business needs)

Reports To:Operations Manager

Salary Range: $76000 - $103000

Purpose:

Invagen Pharmaceuticals is searching for experienced candidates for the position of Production Supervisor. This person will manage the production staff and oversee the production processes.

Scope:

The Production Supervisor ensures compliance with cGMPs InvaGen Pharmaceuticals policies standard operating procedures and FDA requirements. The incumbent will serve as a key resource for conducting product complaints supports packaging packaging components within approved procedures and regulatory requirements. This position reports to the Site Lead/Operations Manager at InvaGen Pharmaceuticals Inc Fall River MA.

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

• Schedule the production process including setting specific targets for phases of production.
• Delegate responsibilities for production to team members and creating team leadership positions to oversee groups of employees.
• Manage performance and train assigned employees using Company systems procedures policies practices and other tools to meet established performance standards productivity targets and overall business requirements.
• Conduct performance assessments and compiling reports on the production process to identify areas where efficiency can be increased.
• Perform raw material and component review to ensure correct quantities labeling and visual appearance.
• Perform weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up verification leveling and challenging.
• Follow Master Batch Records for the packaging of MDIs dosage forms when required.
• Identify defects and report quality issues.
• Set up operate and clean in compliance with batch records and SOPs packaging equipment.
• Clean and sanitize packaging equipment per SOPs.
• Complete accurate and timely documentation. Follow good documentation practices in accordance with cGMP.
• Perform in-process testing and inspections as required by Master Batch Record (weighing visual inspection etc.).
• Effectively performs activities and applies knowledge in accordance with approved SOPs company policies regulatory requirements schedules and provides technical expertise and direction to colleagues.
• Actively participate in Production team and Site communication meetings.
• Support GMP investigations and events.
• Contribute to Standard Operating Procedure (SOP) writing in technical area.
• Understand and operates all necessary equipment and instrumentation to perform activities.
• Maintains documentation in accordance with internal procedures and regulatory requirements (i.e. GMP SOPs etc.).
• Interfaces with appropriate Warehousing Planning Operations and Quality management to implement the procedural requirements as outlined and within internal operating procedures.
• Performs activities for manufacturing (i.e. batch record review packaging line clearances and manufacturing room clearances deviations etc.).
• Comprehend and adhere to all pertinent EHS regulations policies and procedures and the required use of all approved and issued Personal Protective Equipment.
• Responsible for compliance with documentation and accountability procedures and policies maintaining high alert to diversions.
• Demonstrate a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; recognize safety and health related issues and report to management.
• Independently searches gathers and presents information to support compliance with regulations and internal systems.
• Ensure and compliance with safety quality productivity and performance expectations and execution of manufacturing and packaging operations.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP) complying with legal regulations monitoring environment.
• Perform other duties as assigned.

Education and Experience

• Bachelors degree in pharmaceutical engineering Pharmaceutical Sciences or related field of study from an accredited college/university required.
• Masters degree in Pharmaceutical Engineering Pharmaceutical Sciences or related field of study from an accredited college/university preferred.
• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Capable of conducting troubleshooting investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• 3 years experience in a pharmaceutical setting preferred.
• General ability to perform basic to complex mathematical computations of addition subtraction multiplication and division. Understanding of the Metric System of Measurement.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.
• Packaging with serialization preferred.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language.
• Ability to read write and communicate effectively.
• Ability to understand and analyze complex data sets.
• Knowledge of good manufacturing practices and good documentation practices preferred.

• A strong understanding of work discipline Chain of Command and Teamwork
• Able to apply knowledge and experience to complex problems and offer recommendations.
• High standards in Safety Environmental and Leadership
• Self-motivated with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Basic computer skills (Word and Excel) Intermediate
• Good basic math knowledge and excellent attention to details.

Work Schedule and Other Position Information:

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing and able to work any assigned shift ranging from first second or third shift. Work schedule may be Monday to Friday Tuesday to Saturday or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.

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 Indias 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 Ciplas 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.

EEO Statement

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color age sex sexual orientation gender identity religion national origin genetic information disability or protected veteran status.