Job Description

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients\' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

This role is responsible to review and to approve of computer software validation documentation. As the Quality Assurance approver, this role works closely with the software development teams as well as the validation team to assure procedural and regulatory requirements are met.

Essential Duties and Responsibilities:

• Follows West procedures on computer validation, supports the validation of GMP software and process improvements to software.
• Approver of computer software validation documentation
• Works closely with Development team to document requirements for Quality applications.
• Approves protocol execution deviations.
• Approves computer software change control documentation.
• Performs Regulatory Compliance Evaluations and Periodic Reviews based on West procedures
• Actively maintain and improve team\'s awareness of Quality processes, policies, and procedures through training.
• Assures compliance to software as a medical device regulations and procedures
• Reviews and assures software design history file is complete and current
• Other duties as assigned.

Basic Qualifications:

• Education: Requires Bachelor\'s degree in science related field, or Information Technology
• Experience: 5-10 years in Medical Device or Pharmaceutical Software validation.

Preferred Knowledge, Skills and Abilities:

• Good understanding of Software Development in Pharma/ Medical Device Industry, specifically software as medical device
• Ability to work in a team environment. Ability to work independently with minimal supervision
• Motivated and willing to learn
• Basic understanding of different validation tools like HPALM, JIRA, SolMan, DevOps
• Working knowledge of cGMP requirements for process and software

Travel Requirements:

• Travel 10-35%

Physical & Mental Requirements:

• Position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May need to stand or sit for extended periods of time
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms
• Use written and oral communication skills
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

West Pharmaceutical Services