Under the direction of the QA & Regulatory Manager, maintain, support andimprove the Quality Management System at Tarvin. To interpret and advise on the GMP’s associated with Medical Device manufacturing / testing. To ensure that the manufacture / testing of products comply with the relevant International Quality and Regulatory standards ISO13485, FDA.Responsibilities:Product Release and Batch Review ProcessesTo support the batch documentation review process, including the release of sterile and non-sterile products, to make sure they reviewed in an efficient and timely manner and making quality decisions on product and to advise on and assist with solutions.Document ControlCoordination of the documentation control process, the creation, maintenance, review and approval of key documents and procedures.in addition, provide support to the Regulatory Affairs Officer in creating and maintaining Technical Files.ComplaintsCoordinate and monitor all customer complaints to aid in the timely progression and closure. Work with departments providing information for risk evaluation. Support investigations and actions associated with complaints. Liaise with customers to ensure customer satisfaction is achieved.Control of Non-Conformances Manage through to compliance the NCR, Deviation and CAPA process in a timely manner. Coordinate NCR, Deviation and CAPA documents and track status of corrective actions to ensure documents are complete and all corrective actions closed.Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgements within general operating guidelines.Generate metrics for Non-Conformances, Complaints and CAPP's and communicate at the Quality Meetings.

Support the Head of Quality in creating and maintaining a Quality Management System that meets applicable regulatory and company requirements including accreditation to ISO 13485:2003. Lead auditor in the internal audit process of the company’s quality system.Coordination and monitoring on a regular basis to aid in the timely progression and closure of complaints.Conduct and support investigations and corrective/preventive actions associated with complaints.Working with other departments providing information for risk evaluations and reportable events.Liaising with Customers to ensure complete customer satisfaction is achieved

Support the QA/RA Director and Management Team in driving manufacturing excellence and cultural change/improvement.To make quality decisions on product . Ensuring quality requirements and manufacturing/production requirements are considered without detriment to eitherStreamline QMS processes and proceduresSupport product returns and rework process.Manage Deviation and CAPA process in a timely manner.Coordinate Deviation and CAPA documents and track status of corrective action ensuring closure in a timely manner.Create and distribute status reports to Engineering and management staff. Work with and obtain evidence for CAPA from suppliers internal and external.Coordination of the documentation control processResponsible for review and approval of documents and procedures.Generation of Quality documentsReview all quality documentation from Improvements plans, complaint investigations and audit reports for quality and appropriate findings & corrective actions prior to submission for final approval.Internal Audit process.Participate as a lead/second auditor in the internal audit process of the company’s quality system.Support the coordination of the audit schedule, plan and database.Follow-up on internal audit reports and corrective actions ensuring closure of in a timely manner.Submit status reports to management.Generate and communicate metrics to the organization.Support the training of new internal auditors.Generate audit checklists to support internal/external auditsComplaints:Coordination and monitoring on a regular basis to aid in the timely progression and closure of complaints.Conduct and support investigations and corrective/preventive actions associated with complaints.Working with other departments providing information for risk evaluations and reportable events.Liaising with Customers to ensure complete customer satisfaction is achievedReview all Generate reports and communicate metrics to the organization

Reporting to the QA/RA Manager for all non-conforming issues and making quality decisions regarding resolution.Supervise the test lab prioritising work and resolving any issues on a day to day basis.Support the manufacture, production and testing of the Humira injection pen supplied to Abbott Laboratories (Chicago) in the USA.To monitor and ensure compliance with international Quality and regulatory standards ISO 9001:2008, ISO 13485:2012, FDA (part 820)Ensuring quality requirements and manufacturing/production and testing requirements are considered without detriment to either.Perform other responsibilities as directed by the QA/RA Manager.Responsibilities:Control of non-conforming processManage and co-ordinating deviations and CAPA’s in a timely manner, reporting to the QA/RA Manager and customer in the USA by way of conference calls and or personal interaction.• Track status of corrective actions to ensure CAPA documents are complete and all corrective actions are closed in a timely manner.Investigate non-conforming product and reach resolution to prevent further occurrences.Prioritising work for the test lab on a day to day basisReview and approve all test lab documentation.

Responsible for the co-ordination and investigation of Manufacturing Operations non-conforming events. Applied quality tools and techniques to facilitate the resolution of quality issues. Highlighted improvements and recommended relevant Corrective and Preventive Actions. Advised Management, Unit Quality Engineers and Manufacturing staff on actions required for containment and initial investigation requirements. Produced metrics to track non-conformance in order to assist with continuous improvement and to ensure that the company meets quality system standards and targets. Coached / Trained other Quality Co-ordinators / Investigators to a high standard in understanding the Quality System and regulatory requirements of the business. Supported Quality Initiatives including identification of opportunities for improvement. Audited, updated and reviewed manufacturing procedures to ensure compliance with worldwide regulations. Performed Internal Audits and supported the preparation and execution of external audits such as FDA and ISO.

Raised and progressed necessary change requests using an electronic Data Management System (DMS). Raised and progressed Corrective and Preventive change requests for the Compliance Group and Management. Liaised across all shifts when initiating change requests to ensure feedback is sought and incorporated into the changes wherever possible. Controlled, reviewed, updated and written Standard Operating Procedures for the Manufacturing Department. Conducted monthly Internal Audits of training records for completeness and compliance with company procedures and quality standards (GMP). Conducted procedural training for manufacturing personnel.

Processed batches through the packaging process to Good Manufacturing (GMP) and quality regulations. Trained new employees on equipment and manufacturing processes. Completed batch records in accordance with Good Manufacturing Practice (GMP) and quality regulations. Liaised with cross-functional departments.

Discussed various issues with customers and ensured a satisfactory outcome (Customer Service) to their queries. Inspection of finished product, attention to detail essential. Deliveries of completed products to clients, ensured all orders were on time. Inputting customer orders and data into the computer system.