QA Lead - Engineering Facilities Support

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 Fifteen 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.

Responsibilities

Essential Duties and Responsibilities

• Review of engineering documentation, protocols, records, and other related materials—both pre- and post-execution—pertaining to Engineering, EHS, and Facilities. This review is conducted in alignment with Good Documentation Practices (GDP), area specifications, defined parameters, and applicable regulatory requirements.
• Review equipment qualification/calibration/validation documents and computer system validation packages.
• Ensure adequate controls are implemented to achieve and maintain facility qualified state for their intended use.
• Review all pest control documentation and pertinent documentation from contractors.
• Communicate effectively with cross functional departments to ensure on time delivery of facilities and engineering documentation.
• Compile and review all applicable engineering and facilities documentation that is pertinent for batch review and release to ensure all QA batch disposition deadlines are met.
• Ensure adequate control of EM for temperature, humidity, pressure differentials. Perform review of investigations related to non-conformities related to EM.
• Review of tests results generated in support of environmental monitoring (EM) (viable and non-viable). Initiate QE for EM results not meeting acceptance criteria. Perform trend analysis and generate trend reports.
• Review of Quality events, incidents and deviations related to the facility, equipment and engineering and their impact on manufacturing processes/operations and laboratory operations.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
• Serve as Subject Matter Expert (SME) during regulatory and internal audits as it pertains to quality systems and programs.
• Check all engineering and facilities notebooks and associated documents for correctness of raw data
• Keep track of data and records review indicators from engineering and facilities for internal quality metrics and annual product review as appropriate.
• Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, create and revise relevant SOPs.
• Review all qualifications, validation and optimization reports.
• Ensure engineering and facilities staff follow all relevant SOPs and cGMP regulations
• Ensure notebooks are reviewed in a timely manner, in accordance with SOPs.
• Perform additional tasks as assigned by QA supervisor.
  
  

Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences discipline.
• 6 years’ experience within the QA group in pharmaceutical, biologic, medical device or regulated industry.
• Previous experience with equipment/facilities management systems, cGMPs, EU GMP Annex 15, ASTM E2500, ISPE guidelines and ISO14644 standards for cleanrooms are preferred.
• Understanding of SOPs, validation/qualification concepts, HVAC, water systems, ALCOA and data integrity procedures, guidelines and requirements.
• Previous cGMP/regulatory experience is preferred.
  
  

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

Search Firm Representatives Please Read Carefully

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin . No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails