- To work in an actively promote compliance with Company and Regulatory requirements and to ensure that proprietary information is protected at all times.
- Responsible for the recording and investigation of Non conformances and CAPA using root cause analysis tools where appropriate and regular reporting on NCs and CAPAs.
- Responsible for NC and CAPA process management and regular reporting of KPIs
- Deputise for the QARA Manager & RP where appropriate
- Support the QA/RA Manager & RP in ensuring that a quality management system (QMS) is implemented and maintained including quality risk management, documentation management, non-conformance and CAPA, change management, deviation processes, internal and supplier approval and audits as well as measurement of performance indicators and management review
- Take ownership for assigned projects and tasks, completing them within designated timeframes.
- Manage the internal audit schedule and hold internal auditor monthly meetings.
- To review documentation for accuracy and compliance with cGDP and MDD/MDR. This will include, but is not limited to, review of project documents, specifications, BOMs, change controls, validation protocols and standard operating procedures (SOPs), custom pack documentation & packaging submissions.
- To support the supplier assurance program including the approval of suppliers
- Establish, implement and support the maintenance of the Labour Standards Assurance Scheme (LSAS)
- Support the change control process.
- Give QA oversight and provide support to activities within the company (UK)
- Support the risk management process and liaise with key stakeholders to reduce or mitigate any identified risks.
- Maintain knowledge of site policies and procedures, especially the quality system
- Develop and maintain working knowledge of ISO13485 & ISO9001, MDD/MDR, GDP, ISO27001 and LSAS requirements.
- Support regulatory and customer audits when delegated by the QA/RA Manager/Management representative & RP.
- Report all issues to the QA/RA Manager in a clear and timely manner.
- Communicate effectively with other employees and participate with them in planning and problem solving activities, as required
- Support the company (UK) in their commitments with business responsibilies
- Satisfactorily complete all cGDP and safety training in conformance with departmental and site requirements and timelines
- Generation of quality reports such as change controls, overdue SOP reviews, overdue NCs & CAPAs, overdue change controls etc.
- Hold Departmental meetings to go through NC, CAPAs, Change Controls, Document updates, Risk Assessments.
- Support the internal audits/self inspection schedule and perform audits against cGDP and standards; ISO9001, ISO13485, ISO27001, ISO22301 & LSAS as the schedule dictates and maintain an inspection ready status.
- Perform local area and local system audits.
- Training/coaching of operations/sales staff & QA peers
- Generation, issue and archive of non-project and project-controlled documentation
- Create all metrics associated with the QMS and report these to the QA/RA Manager, also feed these into the BMR and monthly reports.
- Proactive generation and timely review/implementation of change controls in conjunction with other personnel
- Take the lead and support where appropriate in the quality aspects of the company's pack assembly process in line with Article 12 of the MDR 2017/2
- Training for other members of the team and the business in the PPA QC Inspections and Chloraprep defects
- Support and monitor the company's temperature monitoring system and raise non-conformities/deviations as required.
- Have a good working knowledge of windows applications (Word, Excel etc)
- Have good interpersonal skills with the ability to appropriately challenge others behaviours.
- Have good time management.
- Be able to analyse data and provide reports where required.
- Be well motivated with the capacity to work under pressure with a flexible attitude towards work.
- Have the ability to liaise with staff, suppliers and customers at all levels in a confident manager.
- Be thorough and pay attention to detail.
- Have good communication skills (oral and written)
- Ability to work as part of a team and unsupervised.
- Good knowledge of the principals and guidelines for GDP as set out in the 'Green Guide
- Experience of working a medical device or pharmaceutical quality function
- Qualified Internal Auditor
- Good knowledge of the requirements of the MDD/MDR as well as ISO13485 & ISO9001
- Ability to work in matrix teams.
- Experience of working with multiple QMS systems
- Understanding of the requirements of GDPR & ISO27001
- Basic knowledge of the principles of Lean six sigma and its application
- Relevant Science or Engineering based HNC/NVQ level 3 such as chemistry, biology or physics.
- Experience of working a busy office environment
- Ability to travel across the UK and internationally.
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Senior Regulatory Affairs Associate - Swindon, United Kingdom - Irecruit4
Description
iRecruit4 is representing a prestigious company in the Swindon area with a with a reputation for delivering high quality products and excellence in customer service. We are looking for a Senior Quality Assurance AnalystFor this role as a Senior Quality Assurance Analyst your skill set will be the following-
Your Experience:
Relevant experience in Quality Assurance role in similar industry.
Overview of the Role
Part of the QA RA team to support the business in all aspects of QA RA activities and promote a quality culture and to deputise for the QARA Manager & RP as required.
Key Duties & Responsibilities
Profile:
You will:
Desirable:
IF YOU FEEL YOU HAVE THESE ATTRIBUTES AND SKILL SET, PLEASE APPLY TODAY FOR THE SENIOR QARA ASSOCIATE ROLE
