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Acorn Recruitment is seeking an interim Validation Specialist for a global pharmaceutical business in Cardiff, South Wales. Rate per hour - £competitive Duration of contract - 3 months Working hours 38 - Monday to Thursday 08:00 - 16:30 and Friday 08:00 - 15:30 Main purpose Enhance validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects Main tasks * Maintain all validation compliance activities in a timely manner in line with the Site Validation Plan. * Work closely with all site departments reliant on validation support to facilitate validation aspects of all projects. * Advise and contribute to Process Flow and Risk Assessment activities. * Draft Validation Plans, Protocols and Reports when required. * Subject matter expert within Investigations, CAPA, Quality Events. * Functional expert for Change Request Impact assessments when delegated or in absence of Validation Section Leader * Report validation status to Validation Section Leader * Be aware of updated regulatory guidance and modify site procedures accordingly to maintain compliance * Contribute to the Validation Community of practice when required KEY RESPONSIBILITIES & ACCOUNTABILITIES: * Ensure that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation. Maintain and support the updating of Validation Schedules within a team based validation structure. * Author or review and approve the development and implementation of Validation Master Plans, protocols, reports and standard operating procedures relevant to Validation. * Technical input into all Validation Lifecycle activities as part of a cross functional team. Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body and international), International Standards, and quality/validation regulations and guidance documents. * Schedule and coordinate the review of process and equipment validation and re-validation / periodic review in accordance with the established Company validation policy and associated procedures. * Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements. * Provide support to the global organisation, (e.g. participating in the Validation Community of Practice) as appropriate, relating to validation activities and associated regulatory activities and procedures. * Serve as subject matter expert and/or team member to support Quality Investigations, CAPA, customer complaint reports, audit findings, failure investigations and continuous improvement opportunities. Ensure accurate and timely resolution and closure to all issues. * Contribute to and perform related training on site with regards to validation lifecycle and compliance. * Prepare and present validation reports and Key Performance Indicators for management review. Review and monitor trends; initiate continuous improvement opportunities, communicate any matters outside the norm to the Validation Section Leader / Site Director of Quality. * Support the IT department to ensure compliance with software and hardware validation regulatory requirements. Provide support in achieving / maintaining compliance with 21 CFR Part 11 / EU GMP Annex 11 and other guidance documents as appropriate to business needs. * Comply with all statutory and Company requirements for health and safety. * The above list is not exhaustive and the job holder may be expected to perform other reasonable tasks within the boundaries of their skills, in the interest of the job and the Company's performance. Skills and knowledge * Bachelors / Undergraduate Degree in a science or engineering related discipline (chemistry, biology, process engineering, pharmaceutical or medical technology preferred). Alternatively, in house or external training in Validation, Quality and Regulatory activities. * Previous Validation experience in Healthcare/Pharmaceutical manufacturing/packing, medical device or biologics industry. * Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization. * Demonstrated expertise in cGMP's, EU/FDA regulations, GAMP guidelines, assessment of risk and drafting of plans, protocols, reports and procedures * Demonstrated understanding of Quality Assurance, Quality Control and Validation Risk Based Principles * Demonstrated computer skills and a working knowledge of basic computer software (Microsoft Office, Excel, Visio etc. preferred) * Demonstrated verbal and written communication skills, including the ability to conduct oral presentations * Demonstrated success working within a team environment * Ability to travel by car and/or plane, typically up to 5%. Additional travel may be required based on business need. Acorn Recruitment Ltd is acting as an Employment Business in relation to this vacancy
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About the role Passionate about cars as you are customer service? Do you possess auto knowledge, gained through working in the auto industry or as a hobby? (Ideally you will know how to fit 3 of the following; bulbs, blades, batteries, car seats, roof boxes). Then how about considering a career as a Halfords Auto Fitter! In this 'hands on' car maintenance role you'll find yourself fitting roof boxes, car seats, bulbs, blades, batteries and much more! You'll deliver exceptional customer service and specialist knowledge around the benefits of car maintenance and servicing. Every day will be an opportunity for you to both learn and utilise your mechanical skills and knowledge! If you enjoy working in a fast paced busy environment with plenty of variety and chances to learn new things then you will love Halfords! About you Bring your auto experience, along with your personality, enthusiasm and passion for cars, Retail and Customer Service and we'll give you the tools and training to be a success! From our 3 Gears training and Retail Level 2 Qualification to our Step up Programmes (up to Area Manager), Apprenticeship and Graduate schemes, the scope for development really is in your hands! If that's not enough to tempt you, we'll offer you the following benefits • A competitive salary • Annual leave starting at 5.6 weeks increasing to 25 days holiday plus 8 bank holidays • 25% colleague discount • Employee Assistant Programme • Save As You Earn share scheme • Access to a range of shopping discounts at high street retailers • Healthcare cash plan (self and family) • Long service awards • Trade Price Bike Scheme • Training courses available via our E-learning hub • Uniform About Us I'm sure you've heard of Halfords, after all with over 110 years' experience synonymous with travel, we're a household brand in the UK and ROI. In a nutshell, we're the UK's leading retailer of automotive and cycling products and also a leading independent operator in car servicing and repairs. In terms of success, our strategy is going from strength to strength - our aim to deliver group sales in excess of £1 billion by the end of financial year 2016 was actually achieved by the end of financial year 2015, a year ahead of plan! In the retail world this puts us in a great place. And just to add to this success, for the second year running we're one of the Sunday Times 'Top 25 companies to work for'. Advertised: 10 Oct 2017 GMT Daylight Time Applications close
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My client within the WHQS Programme is looking for a Clerk of Works / Housing Surveyor assigned to the HRO/PSH to assist in the provision of the efficient and effective repairs and maintenance service and the delivery of associated housing management services. Grade: 7 Working pattern: Monday-Friday 8:30-16:30, 37 hours a week Key task profile: Undertake pre and post inspections and contract duties and assist in the preparation and control of contract works and response maintenance when required. The post holder will work as part of a team to monitor and issue directions/instructions to contractors undertaking WHQS improvements, and to provide a comprehensive repairs and maintenance service. Experience: Essential: Previous experience required in a building maintenance, repair service or equivalent business environment. Experience of working with asbestos. Examining risk assessments, plans of work, etc. Desirable: Experience of advising operational supervisory staff, and experience of Construction Design Management (CDM) Regulations. If you are interested, please contact Henrietta Szocs on 02920007073, or email (url removed) with your up to date CV. Skills Required Ability to carry out site surveys, recognise building defects, analyse, evaluate and offer a solution. Ability to read and prepare drawings, schedules, safety plans, programmes, reports and specifications. Good diagnostic skills and experience to pre-inspect and diagnose requirements for repairs, new installations or refurbishments. Ability to co-ordinate and organise technical information. Good IT skills, ability to utilise technology in the workplace. Ability to assess and deal effectively with tenants queries on a daily basis with a full commitment to the principles of Customer Care. Able to communicate effectively at all levels with good negotiation and interpersonal skills. Able to work on own initiative and as part of a team and demonstrate a professional and flexible approach to work. Able to work under pressure, organise and prioritise workload, meet tight time-scales and make sound decisions quickly. Completes workload within timescales set. Keeps track of own tasks. Updates others when they spot a problem. Desirable: Welsh language skills Good management skills Qualifications Required Essential: Relevant Level 3 qualification on the Credit and Qualifications Framework. Desirable: A recognised professional qualification in a relevant discipline. Relevant Level 4 qualification on the Credit and Qualifications Framework. For example HNC Building Surveying. P402 Asbestos Certificate. IOSH Managing Safety
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My client within the WHQS Programme is looking for a Quantity Surveyor in Caerphilly to work within a team preparing tenders and carrying out valuations. The successful post-holder will be assisting the Project Manager in the provision of an efficient and effective Quantity Surveying and Contract Management Service. Duration: 9 October 2017 – 2 July 2018 Work pattern: Monday-Friday, 37 hours per week Key responsibilities: -Providing quantity surveying and estimating services for internal and external schemes to ensure the best use of available resources. -Preparing tender and contract documents, including bills of quantities with the architect and/or t the client. -Undertaking cost analysis for repair and maintenance project work. -Assisting in establishing a client’s requirements and undertaking feasibility studies. -Performing risk, value management and cost control. -Advising on technical aspects of procurement strategy. -Identifying, analysing and developing responses to commercial risks. -Preparing and analysing costings for tenders. -Assist the Project Manager in the creation and maintenance of a schedule of rates. -These are the core documents utilised for the control and expenditure of the WHQS implementation program. -Providing advice on contractual claims. -Analysing outcomes and writing detailed progress reports. -Valuing completed work and arranging payments. -Maintaining awareness of the different building contracts in current use. -Supervisory responsibility for 1x Estimators. Essential experience of: -working in a construction or related are of work -leading negotiations with clients, partner agencies etc. -multiple project management -co-operative work with both the public and private sector If you are interested, please contact Henrietta Szocs on 02920007073, or email (url removed) with your up to date CV. Skills Required -Detailed knowledge of the technical, professional, legal and commercial issues associated with the WHQS programme -Understanding the implications of health and safety regulations -Knowledge of financial and contract documentation / regulations -Ability to analyse and evaluate information from diverse sources and make appropriate decisions -Good interpersonal skills and communication skills -Strong customer care skills -Commercially aware -Self-motivated, adaptable and resourceful -Effective planning and organisational skills -IT literate Qualifications Required -Essential: Recognised RICS or CIOB professional qualification at degree level or equivalent -Desirable: Management qualification in a relevant discipline, Associate Membership of APS
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  • £30000 - £35000/annum + Benefits
We are currently recruiting for a L&D Officer to join our client based in Caerphilly. This is a full time, 6 Month contract offering a competitive salary and fantastic benefits. We are looking for candidates with previous experience in and L&D function and knowledge of the apprenticeship levy would be a bonus. This is an immensely challenging and rewarding role where attention to detail and credibility are key. Main Duties of the L&D Officer include: * Fully design engaging L&D material that helps continuous learning and development in an individual/team with a particular focus on Management Development. * Working with SME’s to help develop material to make sure it accurately reflects the organisations needs. * Evaluate the training programs delivered to make sure the development offer is where it should be. * Asist the wider L&D team with the L&D agenda and leading by example. To be considered for the role of L&D Officer, you will have: * Exceptional knowledge about a range of learning interventions and methods available. * An in-depth and positive track record of designing, delivering and evaluating training. * Software packages – Microsoft Word and Excel, Photoshop and Adobe based products. * Ability to work with limited supervision. * Excellent communication skills and the ability to work with a multitude of different personalities. Please contact us ASAP if you have the skills required for these positions. We would like to thank you for taking the time to apply for this vacancy. If you are not selected for this particular position, your CV will be kept on file and you may be contacted for other suitable roles in the future
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