Christopher Swift Email & Phone Number

Shifnal, Gb

Chester, England, United Kingdom

 Assisting the Head of Regulatory and the Vigilance team in activities and requirements within the company to achieve and maintain an effective complaint/vigilance system Ensuring regulatory compliance and transparency of complaints and adverse events within the organisation in line with the Company’s policies, procedures, and applicable regulations Logging adverse event reports, incidents and complaints received by the company relating to the medical device portfolio in line with SOPs Performing decisions on reportability for complaints Following up adverse event reports, incidents, and complaint investigation Liaising with affiliates, partners, manufacturers, medical advisors and insurers as part of investigations Preparation, review, and submission of Post Market Surveillance Data, including PMS Tracking, leading in PMS Board Meetings, PMS/PSUR Reports, PMCF Plans and PMCF Evaluation Reports, and trending Assisting with the provision of Vigilance training Supporting the review and update of Complaint and Vigilance SOPs Chairing of Complaint and Vigilance meetings as appropriate Researching up to date Complaint and Vigilance legislation and guidelines and advising management of upcoming changes Ad hoc Vigilance tasks, such as product transfer projects, as required by the Director of Compliance.

Telford, United Kingdom

 Working within the Textiles department looking after the quality aspects of three (plus derivatives) of the company’s core products Working to ISO9001 and ISO14001 standards Investigating both internal and external customer complaints using data driven analysis to determine root cause Implementing and educating new product knowledge and the importance of maintaining standards to ensure product quality Lead quality representative for projects in the Textiles department Creating and implementing procedures and work instructions Reviewing operating procedures, work instructions, standards and SSOW when updates occur Reviewing Quality Inspector check databases Databases created for numerous areas to help collate required data for specific tasks  Daily reporting on defect figures, Q to E, Quality Reviews and monthly senior management presentations Implementing and maintaining 5S as the department’s 5S Champion Additional training: FMEA, COSHH assessor, spill management Institute of Leadership & Management Level 3: Distinction.

Birmingham, United Kingdom

 Working within the Reagent Filling department to ensure that quality and regulatory standards are maintained to remain compliant Working to ISO9001/13485 and FDA CFR 820 part 21 standards Investigating non-conformances and liaising across numerous departments to reach swift resolutions Investigating customer complaints Root cause analysis Building comprehensive reports to assist with maintaining customer confidence Proofreading and approval of operational procedures Implementing 5S standards

Keele

• Technical writing of SOPs for use within a GMP biological production environment• Updating of current SOPs which require review and proofreading prior to publication• Assuring quality management systems are adhered to within an extensive bio-manufacturing facility• Qualified in clean room grade C and grade D change procedures• Monitoring of clean room conditions to ensure that products are manufactured according to customer requirements and GMP standards• Releasing of rooms following thorough QA checks in a timely manner so that quality production can resume safely• Auditing of bio-manufacturing facility to ensure compliance to MHRA and FDA regulations

Ware, Hertfordshire

• Combining micronised active material for medical devices whilst adhering to GMP guidelines set out by pharmaceutical regulatory bodies• Trained in sieving and dispensing processes according to specified recipes• Consistently achieved daily targets in order to meet planning schedules• Extensively trained in GMP, global and local SOPs, and quality inspection

Wolverhampton, West Midlands

First Class BA (Hons) Creative and Professional Writing

Ware, Hertfordshire

 Extensively trained in G.M.P., global and local S.O.P.s, and quality inspection Assisting in writing and updating S.O.P.s to comply with changing standards and practices Frequently exceeding daily production targets set by the planning department in order to consistently meet customer demand, often achieving the highest output as an operator across the shift Meeting cost and quality targets while working safely Skilled in Systems, Applications and Products in Data Processing (S.A.P.) Mentoring and training members of staff on new ways of working, computer use and S.A.P. processes Frequent completion of internal quality and safety audits to ensure working environment is audit ready Implementing projects successfully such as 5S standards, new methods in line clearance, and continuous improvement for the prevention of manufacturing deviations Ensuring working schedule is adhered to and updated in real time Carrying out thorough inspection using X-ray to ensure no defective products are sent to the open market Accurate and clear record keeping at all times

Ware, Hertfordshire

• As listed above for my most recent role at GlaxoSmithKline

The Woodbridge Inn, Coalport, Shropshire

 Ensuring guest experience surpassed expectations through attentive customer service, receiving excellent personal reviews from management and from the public on popular restaurant review websites Dealing with customer complaints, special requests and all aspects of hospitality Trained in food handling, preparation and hygiene Responsible for handling of payments, group bookings and staff organisation

Ware, Hertfordshire

• As listed above for my most recent role at GlaxoSmithKline

Hertford, Hertfordshire

 Counterfeit investigation – researching the origin of products and providing evidence for traceability purposes to meet customer requirements Direct contact with customers including the MOD, BAE and other military organisations in order to discuss product order fulfillment Liaising with internal and external departments for projects and incident investigation Selected above existing workforce to be trained in laboratory testing for authenticity of components using X-ray, XRF and decapulisation Trained using IDEA 1010 standard ISO9001 and AS9120 certified company

London, United Kingdom

• Operating and maintaining food manufacturing equipment• Working within the HACCP and Food Standards guidelines• Fault-finding and diagnoses• Reporting and recording of data relating to food quality and safety• Carrying out inspections and quality control checks• Maintaining general housekeeping standards

Ware, Hertfordshire

• As listed above for my most recent role at GlaxoSmithKline

Sainsbury'S, Waltham Abbey, Essex

• Forklift maintenance within a food supplier environment• Supplying the work force with safe working equipment

Hendon, London

• Training to become a police officer to protect the public and uphold the law• Working within parliamentary guidelines• Training in fitness and self-defense

Harlow, Essex

• Supplying homebound patients with medical supplies and equipment

Harlow, Essex

• Handling and control of confidential credit information

Harlow, Essex

• Evening sorting and delivery for a global distribution company

Harlow, Essex

• Customer service for the music and entertainment industry• Operating tills and handling money• Replenishing stock

Bachelor’S Degree, Creative And Professional Writing, First

Activities and Societies: Course Representative for 2015/2016. Third Year Representative for 2016 Periodic Review for the School.

Gcse

GCSE B: Design and Realisation, English Literature C: English Language, German Language, Mathematics, Religious Education, Science (Double.