1st Stop Recruitment Haverhill CB9, UK
10 Mar, 2019
Senior QA Officer - Contract Role - Haverhill Our client is a leading pharmaceutical company based in Haverhill with over 40 years' experience in the industry. They are currently looking to recruit a Senior QA Officer to cover a 12-month contract You will to the QA Manager and be responsible for reviewing in-house documentation in accordance with in-house specifications and cGMP. You will work to maintain and manage quality systems regarding cGMP for the Haverhill site and will support or carries out audits and inspections to assure compliance with regulations. You will be interacting with team members of other functional areas to support the Value Stream Goals and Targets Reports to the QA Manager. Your main duties and responsibilities will be as follows: Reviews GMP or regulatory documentation to ensure compliance. Liaises with internal and external third parties and may co-ordinate work done by different groups. Monitors third party compliance and follows up on non-compliance issues to ensure timely resolution or escalates appropriately. Take responsibility for investigating complaints Provides advice and support to managers and resolves routine and non-routine compliance or regulatory issues. May sign off some cGMP or Regulatory documents. Acts as departmental representative in projects or cross-functional meetings. Manages relevant systems and databases. Supports the continual improvement process and will be expected to generate new ideas for review. Has a good knowledge of cGMP, current legislation and regulations and how they impact on their activities. Keeps up to date with changes. May facilitate internal audits and inspections under directions and produce reports and action plans. Perform packed batch and bulk release activities May act as a product steward. Maintains knowledge of an assigned product, including being the point of contact for the business for quality related advice and support for that product May act as a point of contact for quality related advice and support for specific assigned functional areas May act as a Site Standard Owner May act as a Quality IT System Co-ordinator May provide training, coaching and supervision to less experienced QA staff As a Senior QA Officer, you will need to maintain frequent internal contacts across the site or with other client sites and with third party suppliers and builds good working relationships with key contacts. There will be occasions where you will need to respond to non-standard and sometimes complex requests from other departments on compliance matters. Whilst your work will be supervised, you will need to demonstrate a reasonable level of independence within your field of knowledge and be able to organise your time to meet short and medium term deadlines set by others. You will receive guidance from Manager or Project Leader when undertaking new tasks and projects and will have some responsibility within a project team and will support the successful completion of team and departmental goals and projects on time and in budget. Ideally, we are looking for a graduate or equivalent and may be working towards externally accredited qualifications. BSc or equivalent is desirable If you feel you have the skills and relevant experience to fulfil this contract role and are able to commit for 12 months, then please submit your CV in Word.