Job Description

Quality Assurance Operations Specialist

Liverpool, Speke

Opening date - 14/09/23

Join an environment of excellence, where we\xe2\x80\x99re backed by a belief that good can always be better. It means we search for opportunities to add value \xe2\x80\x93 harnessing science and evidence to foresee risk. A place to continuously innovate to find new and better ways to ensure we are improving outcomes for patients!

In this role you will ensure that all batch related activities are controlled while providing quality oversight and support at the source of key operational processes. Providing Quality Assurance support to an assigned area, including out of hours support. The job holder will have proven experience as a Quality Assurance Officer or equivalent.

Typical Accountabilities

• Provide expert advice on Good Manufacturing Practice/Good Development Practice/ Good Laboratory Practice to Operations and ensure compliance with the associated quality standards.
• Advise on deviations and use judgement to recommend approval or rejection of product within tight business deadlines.
• Be able to perform product release activities and recommend batch disposition to the Qualified Person.
• Collate the required documentation for product quality reviews within the required timescales.
• Ensure compliance with change management processes and approval of associated documentation at a local level.
• Apply risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgements, within general operating guidelines.
• Look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
• Produce and deliver Good Manufacturing Practice training across site.
• Drive out any non-value adding activities and support lean operations and support line management to develop a culture of continuous improvement.
• Ensure plant readiness for any regulatory inspections. Plan and lead self-inspections to aid in developing follow-up improvement plans to ensure ongoing compliance
• To review completed batch documentation for compliance with cGMP, product license and company requirements.
• Support general BPD (Development), Manufacturing, QC, Engineering, Supply Chain and Manufacturing Excellence activities.
• Support QC assay approvals (Including GQCLIMS).
• To issue controlled documents/work sheets as required.
• To update and interrogate relevant Quality Assurance Databases.
• To assist in the compilation and issue of Quality Assurance KPIs, including batch right first time metrics.
• To review SOPs, Manufacturing Instructions and other relevant batch documentation for accuracy, compliance with cGMP, license and company requirements.
• To assist with Batch Record Assembly.
• To revise written procedures.
• To participate in scheduled internal & global compliance audits.
• To review, advise and approve upon investigation of out-of-specification results.
• To represent QA in standing meetings, providing input, updates and guidance e.g. Daily Operations meetings and leading QA Tier 2 daily meetings.
• To work with other functional groups to assure timely completion of corrective actions.
• To perform trending assessments on deviations, OOS results and other relevant quality parameters which may affect batch release.
• To lead meetings covering first line manager absence when appropriate.
• To lead work on special projects as required.
• To provide QA support to Materials Management for product/sample shipment and inventory movement
• To perform person-in-plant functions, when required.
• Promote constructive relationships with other functional groups.
• To learn new technology for QA/Production system improvements and help to deliver any training packages associated.
• To perform final review and status labelling of materials (specification generation, review and SAP approval).
• To support Quality Technical & QAD groups (Holiday and absence cover) where appropriate.
• Applies working knowledge of related technical disciplines
• Generates detailed handovers to ensure continuity between shifts where appropriate

Essential

• Expert verbal and written communication skills.
• Experienced knowledge of cGMP standards.
• Good general knowledge of Aseptic Practices
• Computer literate.
• Provides solutions to a variety of quality non \xe2\x80\x93conformances based on experienced knowledge of the process and compliance regulations using QRM and Quality decisions tools.
• Good communication skills to interact with other functions and areas.
• Conflict Management.
• Time management and priority setting.
• BSc. in biological sciences or equivalent.
• Considerable level of scientific experience.
• Considerable level of experience of working in a cGMP environment preferably in the pharmaceutical/biotech industry In QA, QC, or manufacturing and demonstrated knowledge on Quality Systems
• Must have the ability to work independently, whilst remaining organised and capable of coordinating multiple projects with timely results.
• To have strong organisational skills to assure turnaround times are met in support of further manufacturing and final release.
• To be familiar with product development, manufacturing, quality assurance and quality control systems.
• To be able to write standard GxP documentation.
• To possess and exercise excellent communications skills and a proven ability to build and maintain constructive relationships.
• To demonstrate a commitment to quality and is willing to promote quality and lean standards.

Desirable

• SME in electronic quality systems.
• Effective facilitation and management skills to initiate corrective action and change control.
• To be knowledgeable regarding the validation and operation of manufacturing processes and analytical methods and associated equipment, facilities, automation and information management systems.
• To have and maintain current knowledge of the laws and regulations affecting the manufacture and distribution of biological pharmaceutical products
• Must be able to deliver a range of quality training packages within the UK

Why AstraZeneca?

At AstraZeneca, we \'re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We\xe2\x80\x99re on an exciting journey to pioneer the future of healthcare!

So what\'s next! We are really looking forward to hearing from you with your application..

Competitive salary and benefits package.

Closing date - 28/09/23

Date Posted 14-Sept-2023

Closing Date 28-Sept-2023

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca