• Supporting operations providing directed quality engineering support. • Ensuring appropriate risk management documentation such as risk analysis, pFMEA and dFMEA are up-to-date and appropriate at all times. • Reviewing and approving quality related documentation particularly relating to upkeep of manufacturing documentation and Device Master Record of production area. • Supporting operations, manufacturing operations and key vendors in yield improvement activity. • Assisting in the development of process optimisation, applying measurement system analysis and formal process validation techniques. • Leading, facilitating and participating in formal problems solving to overcome production issues. • Compiling and reporting Quality Measurement Indices as required. • Engineering Executive role in handling Non Conformance relating to production concerns. • Perform corrective and preventive action (CAPA) activities.
The ideal candidate will have:
• HND or equivalent calibre in engineering, science or technology discipline. • Preferably minimum of two years in a quality-related field. • Demonstrable risk-based approach. • Preferably exposure to common electronics manufacturing issues. • Preferably experience of a Medical Device manufacturing environment or equivalent (e.g. pharmaceutical or possibly high specification consumer electronics). • Proven problems solving ability (e.g. 8D, KT etc.).
Are you an Experienced QC or Development Analyst looking for work in South Wales? Have you got experience working within a GMP environment? Are you happy to consider 6 months FTC with a view of it going permanent?
To develop protocols and procedures for testing purposes. Development and validation of analytical test methods in an efficient and effective manner in full compliance with relevant documented procedures and pertinent regulatory/company requirements.
QUALIFICATIONS, SKILLS & EXPERIENCE: A degree in a scientific subject as a minimum (preferably Chemistry). Experience in carrying out HPLC, GC, dissolution analysis. Previous laboratory and analytical experience essential. With method development/validation experience?
Previous analytical development experience also essential. Preferably in a pharmaceutical environment. Or if you are a recent PhD or MSc Chemistry graduate looking to gain experience in industry then please also apply to register your interest.
ROLE & RESPONSIBILITIES: · To perform routine laboratory procedures right first time with minimal personal OOS results and if relevant and instructed to do so, to assist others within the team. · To plan and prioritise own day to day workload in line with client requirements and adapt this where necessary in line with client needs and expectations. · To assist in preparation of technical documentation within the Department, as required. · To assist in training of others, as required. · To ensure that all work carried out complies with departmental procedures and is cGMP compliant. · To ensure that all personal lead times are complied with, subject to the absence of attenuating circumstances. · To assist in the performance of project work within the team, as required. · To assist in the development and validation of laboratory procedures within the team, as required. · To assist in the development and validation of laboratory procedures within the team, as required. · To review analytical and laboratory data within the team for accuracy, completeness and compliance with documented procedures. · To communicate effectively with others on site and to assist with departmental problem solving as required.
PERSON SPECIFICATION: Highly self-motivated individual Methodical, organised and have an excellent attention to detail. Able to work both in a team & independently, Good communication skills are essential as role requires the organisation and co-ordination of work with other departments. Minimum two years within a quality assurance environment, preferably in the pharmaceutical industry.
Aptitude tests will be part of the recruitment process.
This company is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic and pharmaceutical markets.
The Senior QA Associate ensures that all QA activities comply with ISO9001, and the site quality management system.
A background in Quality Assurance with good working knowledge of ISO9001 and ISO 13485 or a related discipline is necessary for this role, along with the ability to develop strong relationships with external and internal customers from diverse backgrounds.
You must have the capacity to bring logical thought processes and impartiality to solve practical problems and the ability to work unsupervised and under pressure in a busy fast paced environment.
- Review of batch records. - Identifying and helping to implement improvement opportunities within the QA department - Advising and supporting other departments in QA related issues - Representing QA in inter-departmental / customer meetings as required - Coordination of change control activities - Completion of quality and product-related customer questionnaires - Review of qualification / validation documentation - Maintenance and review non-conformance / deviation database - Maintenance and review customer complaints file - Performing general activities required for the maintenance of the Quality Management System - To work in accordance with site and legislative employment policies and safety requirements.
They deliver exceptional products and technologies that people rely on to enjoy a better quality of life. They embody the phrase "work hard, play hard" and look for their people to be active participants in life, to make work fun as well as challenging.
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