Role: QA Associate
Location: Slough, Berkshire SL1 4DX
Duration: 9-month role with potential to extend
Fully onsite position
Description:
Role Purpose & Scope:
* Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA leadership.
* Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations and enable the Slough Site to deliver to relevant targets.
* This will be achieved by assessing compliance with site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes and where required escalating non-compliance through the PQS, site governance mechanisms and senior QA Leadership.
* Supporting Senior QA leadership to drive continuous improvement.
* Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and client’s Customer expectations.
Key Responsibilities:
* To provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes.
* Advise areas of support on best practice for document completion, review and follow up actions/ escalate if required.
* Acting as a point of contact for general queries relating to Quality and escalating as required.
* Expand and utilize knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel.
* Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs.
* To actively identify, suggest and participate in continuous improvement activities
* Mentor and coach business partners in cGMP practice to maintain and develop a cGMP environment.
* Maintain and promote a state of audit readiness.
* Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects.
Key Stakeholders:
Please specify the stakeholder positions the role will interact with
* Stakeholder 1 Manufacturing
* Stakeholder 2 Material Science and Technology (MSAT)
* Stakeholder 3 Supply Chain
Required Skills & Competencies: (e.g. technical, interpersonal, problem solving) Skills
* IT literate (MS Office – Word, Explorer, Excel, Access, Outlook) familiarity with database entries
* Verbal and written communication skills
* Risk based decision making
* PQS experience
* Accurate data entry skills, high attention to detail
* Demonstrated workload prioritization skills, decision making and scheduling skills
* Ability to meet strict deadlines
* Good organizational and planning skills.
Education/Degree
* Required: Bachelors of Science (or equivalent experience) Field of Study Biology or related field