Pharmaceuticals Investigation Specialist

Location

Somerset, NJ | United States

Job description

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Reporting to the Head of Operations, the Investigation Specialist will lead investigation process and equipment upsets through root cause problem solving methodologies, develop project plans to correct and implement solutions, and drive efficiencies initiatives within operations. The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.

This position will support operations from Investigation and technical writing role within both manufacturing and packaging departments in Somerset, NJ.

• Leads deviation and customer complaints investigations as assigned through use of root cause problem solving tools and technical knowledge / understanding to identify and propose corrective and preventive actions.

• Support leadership to implement and close corrective and preventive action plans and also support change controls.

• Create, revise, and maintain documents such as change controls, standard operating procedures, and qualification protocols.
• Able to technically write and prepare written investigations of findings and

• Demonstrates working knowledge of equipment and processes in the manufacturing and/or packaging of pharmaceuticals and able to take initiatives to advance departmental goals.

• Lead continuous improvement initiatives within manufacturing and packaging in support of operations.
• Support error reduction, lean waste elimination, and reduced process variation that improves product safety, quality, and efficiency.
• Work with cross functional groups to accomplish objectives including procurement, operations, supply chain, maintenance, facilities, technical services, quality assurance, and quality control as appropriate.
• Working knowledge of Systems like Trackwise, SAP etc. will be an added advantage
• Under the supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work and projects led to enable leader’s review and approval and occasional direction in performing one’s work.
• Working hours typically 8 to 5 Monday through Friday or other as approved by

• Carry out all duties in accordance with Good Manufacturing practices (cGMP), Safety protocols and standard operations procedures.

Qualifications and Education Requirements

• Bachelor’s Degree in an engineering, pharmaceutical or scientific Chemical or Mechanical Engineering preferred.
• Required 3 - 6 years of pharmaceutical industry experience in operations, Quality or Tech. Services.
• Strong investigation, analytical and problem-solving skills.
• Strong communication and technical writing
• Working knowledge and fluency in using MS – Word, Excel, PowerPoint. Experience with Track wise or similar QMS systems will be an advantage.

Job tags

Salary