Senior Specialist, Quality Engineer

Shift Pattern: Days
Contract: Permanent


At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements. 
Developing and implementing continuous improvement programs covering production processes and quality management systems.
Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.

Essential Duties and Responsibilities

The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.
•    Review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
•    Review and approval of laboratory test results 
•    Ensuring Data Integrity of laboratory results
•    Assist in the investigation and closure of Laboratory investigations, Deviations and Out of specifications 
•    Communication with External Customers
•    Maintenance of validation status of QC and production facilities, equipment, instrumentation and software via review and approval of planned changes and new process introduction.
•    Review and approve sampling plans & procedures related to manufacture of products.
•    Lead and perform risk assessments and implement control plans.
•    Review and approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
•    Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
•    Support quality systems implementations and user acceptance testing where required.
•    Lead in Continuous Improvement of Quality processes
•    Interact and collaborate with Laboratory; Operations and other functions to support Analytical Laboratory Services  and  production and timely resolution of issues and investigations.
•    Participate in internal audit and Shop Floor audit program
•    Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
•    Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
•    Compliance to all local site Environmental, Health and Safety regulations.
•    Compliance to all local site company policies, procedures and corporate policies.
•    Perform additional duties as required

Basic Qualifications

• Degree in a Quality, Science or Engineering or equivalent discipline.

  Desired:

  • Quality Auditing certification.
  • Lean/Six Sigma certification.
  • Supervisory experience.

Preferred Knowledge, Skills and Abilities

•    5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
•    Review and approval of facility, equipment and process validation
•    Analytical Method, Equipment/Process and Software Qualification
•    Involvement in new product introduction or technical transfer activities.
•    Quality planning and communication skills.
•    Strong technical writing ability.
•    Ability to liaise with customers and suppliers in an informed professional manner. 
•    Excellent IT, communication and interpersonal skills using current office technologies.
•    Ability to work on own init