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Job Description
**Quality Assurance Specialist**
West Pharmaceutical Services is a dedicated team that improves patient lives through the delivery of life-saving and life-enhancing injectable medicines.
We are seeking a Quality Assurance Specialist to ensure internal system compliance and customer specifications conformity. This role will ensure the timely and effective closure of internal/external quality issues.
- Interface with customers to ensure requirements/concerns/complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
- Manage customer documents into the West Quality system, including drawings, purchase specifications, and quality agreements.
- Draft and approve quality documentation to meet West and customer requirements, including quality specification sheets, CAPAs, and defect libraries.
- Trend and track quality data to support quality improvements across the business.
- Lead investigations into material/product issues to ensure a thorough root cause, containment/corrective and preventive action is implemented.
- Adhere to incoming control requirements and support the SCAR process when required.
- Participate in the review of validation protocols and reports to ensure quality compliance.
- Execute internal process and system audits.
- Manage quality projects in support of continuous improvement, including Lean projects.
- Coordinate activities associated with change management and customer interaction.
- Ensure the timely and effective closure of day-to-day quality issues.
- Interface with other departments on a daily basis.
- Analyze and report key measures, including Ppk's, Cpk's, Cost of Quality, Customer Complaints, and Internal/External Quality Results.
- Coach and drive a culture of compliance and continuous improvement.
- Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all site Environmental, Health and Safety requirements, training and regulations.
- Compliance to all local site company policies, procedures, and corporate policies.
**Requirements:**
- Third-level qualification in Engineering/Quality/Science.
- 2+ years work experience in a Medical Device manufacturing environment.
- Working knowledge of quality systems such as ISO 13485.
- Experience and knowledge of 21 CFR Part 820 and EU GMP.
- In-depth knowledge of validations and change control management in a Medical Device environment.
- Working knowledge of statistics & SPC.
- Excellent communication skills, both oral and written.
**Preferred Qualifications:**
- Auditing experience to the requirements of ISO 13485/EU GMP/21 CFR Part 820.
- Working knowledge of Lean/6 Sigma tools.
**Travel Requirements:**
- Must be able to travel up to 5% of the time.
**Physical and Mental Requirements:**
- Must be able to exert up to 10lbs/4kg of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.