A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Who we are: We offer a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Your role: The ideal candidate will have engineering or science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on quality assurance, facility, equipment and process qualification activities.
You will be responsible for managing the quality assurance Quality Engineers and Quality Technicians and all aspects associated with API manufacturing and regulatory requirements for the manufacture of clinical and commercial APIs and other solutions. Areas of emphasis include but are not limited to people management and oversight and implementation of the Quality Management System.
Essential Duties and Responsibilities of this position include but are not limited to:
- Assists the Quality Manager in overseeing and managing all Quality Assurance Systems within the facility. Support the preparation of annual work schedules.
- Supervises the Quality Assurance Staff activities and manages the day to day QA operations to ensure that assigned tasks are performed in a compliant manner within assigned timeframes. Complete Performance Management and Staff appraisals.
- Supports all site Health, Safety & Environment initiatives and requirements and ensures support of same from reports.
- Investigation reporting including Process Deviation, OOS, Material failures and customer complaints.
- Review and approval of batch related documentation and final product release.
- Provide Regulatory and cGMP leadership to all Site and Business Unit Functions.
- Provide a QA input to (and manage, as necessary) company validation programs.
- Ensure the cleaning validation protocol and programs are progressed in accordance with current cGMP norms
- Complete QA audits, inspections and investigations in a timely manner consistent with shipping deadlines.
- Investigates customer complaints and regulatory queries thoroughly, in a timely manner and ensure that all corrective and preventive actions are fully implemented.
- Foster and instill a Continuous Improvement culture within QA and QA related activities.
- Lead and train QA team on detailed Root Cause Analysis investigations related to relevant site and product quality requirements.
- Preparation of APRs, DMFs and other recurring cGMP requirements in a timely manner.
- Maintain an up-to-date knowledge of current international cGMP trends and cascade this to all reports and to Site Leadership.
- Oversee the Plant Documentation and Change Control system including drafting of SOP’s, Monographs and Master Batch Records.
- Ensure full Quality group participation in company improvement functions.
- Provide continuous improvement leadership in QA activities to secure process efficiencies and enhancements.
- Act as liaison point with Regulatory agencies as necessary.
- Act as Lead Host in cGMP audits in the absence of the Quality Manager
- Prepare, authorize, manage and ensure delivery of the company cGMP training program.
Who you are:
- BS in an Engineering or Science related discipline
- 5+ years pharmaceutical, laboratory, manufacturing or Quality Engineering related experience
- Previous experience in pharmaceutical manufacturing/ medical device facility & quality systems.
- Thorough knowledge of cGMPs and SOPs related to Quality.
- Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc.
- Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CAPA).
- ASQ Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired
What we offer: We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!