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Title:  Quality Assurance Validation Specialist

Requisition ID:  45612
Date:  Jan 15, 2022
Location: 

Exton, Pennsylvania, US

Department:  Quality
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:
In this role, you will support Corporate Quality Assurance oversight of Global validation activities. You will interact with team members from all sites to support processes and equipment. You will review, approve, track, and discuss progress on protocols and reports required for compliance with medical device regulations. You will help to identify areas of non-compliance and provide recommendations to resolve quality and efficiency concerns. 

 

Essential Duties and Responsibilities:
•    Perform Quality review and approval of production and validation documents including procedures, protocols, risk assessments, reports, raw data, and stability studies. 
•    Provide Quality support for multiple projects of various complexity with multi-disciplinary departments to ensure timely completion of deliverables.
•    Support Quality oversight of equipment, process, and sterilization validation activities globally.
•    Maintain ongoing status of completed and in-process validation activities and report current status regularly
•    Serve as corporate Quality liaison with diverse sites for support of scheduled activities and resolution of validation issues.
•    Work with company SME to evaluate new regulations, changes to existing regulations, and regulatory trends and to perform gap analyses to determine deficiencies and take appropriate actions.
•    Ensure corporate guidance documents are updated and comply with corporate policies, standards, and practices and reflect corporate Quality expectations for global Validation activities.
•    Other duties as assigned.

 

Basic Qualifications: 
•    Bachelor’s degree in Science, Engineering, or related field required.
•    Minimum of 3-5 years of experience in multiple areas of Validation (e.g. equipment, process, sterilization). Computer System Validation is not applicable to this role
•    Minimum of 2 years Validation experience in pharmaceuticals or medical device industry

 

Preferred Knowledge, Skills and Abilities:
•    Strong understanding of quality and regulatory requirements in the medical device industry (pharma experience may be considered equivalent for highly qualified applicants)
•    Strong understanding of GMPs, FDA regulations, and EU regulations
•    Ability to work in a fast-paced environment and balance competing priorities
•    Self-motivated, independent, and dependable; good team player
•    Effective time management and prioritization skills; outstanding attention to detail
•    Commitment to a positive working environment and respectful of people of all backgrounds
•    Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 
•    Support and contribute in Lean Sigma programs and activities towards delivery of the set target 
•    Able to comply with the company’s safety policy at all times
•    Able to comply with the company’s quality policy at all times


Travel Requirements:
•    Must be able to travel up to 25% of the time 
 

 

 

 

 

 

 

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 Apply.Accommodation@westpharma.com.  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.

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