Manufacturing QA Coordinator

2 months ago

Liverpool, United Kingdom CSL Seqirus Full time

To provide Quality Assurance (QA) oversight of areas of the site and parts of the business as specified.  To be QA point of contact with these areas for quality related issues to ensure that products are manufactured, stored, tested, released and distributed according to their defined specifications.  To manage your team as applicable and maintain compliance with the relevant SOPs/regulations. You will contribute to QA strategic planning and agile resource management.  Reporting to the Qualified Person and Quality Assurance Support Manager.  You will be based on-site in Liverpool.

Responsibilities

  • Responsibility for provision of QA oversight of areas of the site and parts of the business as specified.  Develop relationship with cross functional departments as applicable through attendance at team meetings and area presence to ensure open communication and trust.

  • To manage your team accordingly. Manage all HR requirements of the team (holidays, sickness, timekeeping, end of year reviews and training planning).  To ensure that other team objectives are achieved and to monitor this progress, suggest and support execution of the work plan, suggest and implement improvements to it.  To support team development through coaching and feedback to encourage optimal performance.  To ensure mandatory training is in place and monitoring the training status of the team. 

  • To support the batch release process within QA.  Targeted resolution of quality issues for batches according to the planned release date.  This will also involve progression of deviations, change controls, CAPA’s and other elements of the quality systems accordingly.

  • To promote a Safety, Quality and cGMP culture in the team and across the site.  To ensure appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team and site areas of responsibility in accordance with current regulations and procedures.  Permanently inspection ready and prepared to participate as applicable.

  • To participate in improvement project/investigation teams where required.  Drive quality decisions and provide advice and technical support where required.  Coordinate completion of any resulting activities.  Demonstrate creative problem solving within cGMP constraints and align with best practice.

  • To perform training and attend relevant courses to maintain compliance status for own role.  Deputise for the manager for example in preparation for and running meetings.  To escalate any areas of significant risk including both quality and personnel issues.

Qualifications

  • Substantial experience working in a biopharmaceutical environment.

  • Understanding of EU and FDA regulatory requirements.

  • General experience of Quality Management Systems i.e., (Change controls / Deviations / CAPS’s/ SAP/ Document Control)          

  • Competent IT skills, particularly Excel and Word.

  • Excellent interpersonal skills and communication skills.

  • Ability to work as a member of a team, but flexible to work on their own.

  • Ability to manage multiple sets of information, prioritizing when required, good problem solving and risk management skills.

  • Have a good knowledge of cGMP requirements and applicable process knowledge.

#LI-Onsite


Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

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