QMS and Validation Specialist

The purpose of the QMS and Validation Specialist role is to work alongside the QMS and Validation Managers to establish, manage and implement the QMS and validation program for Rayner processes, systems and products in compliance with regulatory requirements. The position shall also support Rayner’s business objectives, corporate policies, and world class manufacturing.

Your key responsibilities will be:

Cross Functional

• Support the QMS and Validation Managers in the generation, maintenance, and distribution of KPI data to the business,
• Manage and deliver the training requirements for the Quality Department to other staff (includes onboarding, offboarding requirements),
• Assist with external audits as required.

Validation Specific

• Support validation planning with cross functional teams to ensure that an appropriate risk-based approach is taken and then executed in accordance with Rayner procedures to meet project deadlines,
• Support all validation activities, which include the development, writing, execution, review and approval of validation plans, validation protocols and reports (IA/FAT/SAT/IQ/OQ/PQ/VSRs) etc,
• Evaluate, investigate and document non-conformances incidents and/or protocol deviations,
• Participate in the development of new processes, process transfers and continuous improvement, and issue resolution,
• Identify compliance risks associated with Rayner facilities & systems and actions to mitigate risks to required levels.

QMS Specific

• Assist with internal audits as either audit lead or support as required by the QMS Manager,
• Assist in the maintenance, administration, and development of the e-QMS (Q-Pulse) platform,
• Assist in the maintenance, administration, and execution of the Change Control System,
• Manage the archiving of company material, ensuring an efficient system which is easily accessed and used in line with the relevant procedures,
• Support the QMS Manager in establishing and maintaining standard operating procedures for document development, management, and control,
• This includes all documents associated with Quality Systems, such as the Quality Manual, Corporate and facility requirements, manufacturing and quality specifications, Device Master Records, and documentation related to Quality System training.

Competencies:

• Compliance: Conforms to company policies and procedures
• Decisiveness: Makes well-informed, effective, and timely decisions, even when data are limited, or solutions produce unpleasant consequences; perceives the impact and implications of decisions.
• Flexibility: Modifies his or her approach to achieve a goal. Is open to change and new information; rapidly adapts to new information, changing conditions, or unexpected obstacles.
• Teamwork: Contributes fully to the team effort and plays an integral part in the smooth running of teams without necessarily taking the lead.

Qualifications:

Essential

• Degree, equivalent qualification or equivalent experience in a science or engineering background.
• Experience of validation, quality and change control management within a medical device / GMP regulated industry.
• Experience with Quality System concepts, practices and procedures (e.g. ISO:13485, CFR820)

Desirable:

• Working knowledge of cGMP, FDA 21 CFR Part 820 QSR and ISO 13485 Medical Device Quality Management Systems.
• Experience in a validation role within a GMP regulated industry, to include process/equipment/cleaning/computer systems/sterilisation validation.
• Experience of successfully presenting to FDA Inspectors, Notified Body auditors and other regulatory functions.
• Familiarity with statistical sampling techniques.

What you can expect from us: 

• Comprehensive benefits package
• Global appreciation platform to recognise colleagues around the globe
• Fantastic opportunity to work with highly talents teams and individuals and grow with the business
• Exciting variety of engagement events like yoga, seat chair massages, Summerfest, quarterly Love to Learn events
• Free on-site parking for all staff
• On-site restaurant
• Cycle to work scheme
• Being part of an organisation you can be proud to work for changing the lives of millions of people!