Description

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

Responsibility for compliance with the quality and regulatory requirements for combination medicinal and device products assembled and packed by West. This role is also responsible for overseeing the compiling and submitting of technical and quality documents to the relevant authorities in support of obtaining and maintaining the required medicinal product manufacturing authorizations. Reports directly to the Quality Assurance Manager.

Responsibilities

Essential Duties and Responsibilities:

• Reporting to the Senior Quality Engineer of West, this role will be responsible for the upgrading and maintaining of West’s quality systems to meet the requirements of the European and US Medicinal Product and medical device requirement, this includes the establishment, maintenance and continuous improvement of West’s quality systems, procedures and policies.
• Keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact to West and lead updates as required. The responsibility shall also extend to the advice on compliance risk issues and driving improvement actions. Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops. Monitor local Regulatory Environment and feed-back to relevant stakeholders
• Liaise with Customers and regulatory agencies on behalf of West.
• Management of customer documents into the West Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
• Maintain a comprehensive audit readiness program to ensure internal and external compliance for Medicinal Product lines and associated processes
• Develop reports / presentations on the status of the compliance program for West senior management team and the wider West Pharmaceutical Services colleagues.
• Support the Medicinal Product transfer and validation of process and/or assembly lines from a customer or West sites through QMS set-up to meet specification and ensuring an agile and compliant operational system.
• Compile and review all relevant batch manufacturing and test data, including deviations and out of specification investigations, for final approval by the QP
• Liaise with the QP on performance of the QMS and emerging quality trends and risks in order to drive quality improvements.
• Adherence to incoming control requirements and supporting the SCAR process when required.
• Lead Customer Complaint investigation to enhance preventive action and reduction of risk to customers and to our QMS.
• Facilitate and lead risk assessments to ensure compliance and enhance West QMS
• Conduct various Medicinal Product trend analyses to identify short and long range patterns so that recommendations can be made in order to effect continuous improvement necessary to satisfy customer requirements and drive improvements of West QMS
• 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.
• Perform additional duties at the request of the direct supervisor.
  
  

Basic Qualifications

• Minimum requirement is a degree programme in either pharmacy, chemistry, biology, microbiology or equivalent with at least 5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
• Knowledge of and experience of maintaining a QMS which meets the legislative requirement of human medicines and medical devices in the EU and USA and the ISO13485 standard.
• Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971
• Experience of hosting regulatory audits from either the European or US authorities.
• Accredited lead auditor against recognised quality standards in support of internal and supplier audits
• Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
• Must have excellent written and verbal communication skills.
  
  

Preferred Knowledge, Skills And Abilities

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to 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 always comply with the company’s quality policy.
  
  

Travel Requirements

• Must be able to travel up to 5% of the time.
  
  

Requirements

Physical and Mental Requirements:

• Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.
• Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.
  
  

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.