Process Coordinator Downstream

Responsibilities:

The role holder will be a key employee in the manufacturing organisation. They will take a lead role in the day to day running of the department. The role holder will work cross functionally with other departments to ensure safety, quality, cost, service and productivity are maintained. They will help provide (be trained in) the technical skill-sets necessary to manufacture high quality vaccines in a compliant, efficient, and cost-effective manner. Also, to be the DM Manufacturing area improvement project coordinator and support for the department for changes and audit commitments.

When manufacturing ensures that all Departmental SOPs and MIs/MBRs are followed and:

Ensure appropriate control, monitoring and delivery of activities in their area of work.

Ensure that all documentation is completed correctly, accurately in a timely manner and signed by the relevant trained personnel.

Carry out final documentation review and sign off to ensure documentation is right first time.

Ensure compliance to Health and Safety regulations. Consistently demonstrating the behaviours necessary to create a safe working environment for themselves and their colleagues.

Be able to update existing SOPs and MIs as and when required performing regular reviews and initiating new documentation as appropriate.

To actively maintain and promote a cGMP compliant culture, ensure that the highest standards of housekeeping and safety are applied within the area in accordance with the Orange Guide and CFR regulations and to apply the principles of Lean Manufacturing, Problem Solving, 5S ,Waste Elimination and Energy Efficient Activities in support of Continuous Improvement. Coordinate area GMP initiatives and deliver KPI Improvements

Attend all compulsory and allocated training courses required for the role. Ensure that all training is completed in a timely manner and that personal training records are kept up to date. To continue to develop new skills, competencies and behaviours to fulfil both current and future business needs. The role holder will be able to demonstrate the application of the skills required for their role.

To work in a safe manner in compliance with all pertinent UK legislation, Seqirus mandatory policies, guidelines and site procedures for Health, Safety and Environment. The role holder will be expected to promote a health and safety culture within their department and actively own and contribute to HSE Human Factors initiatives.

The role holder will be the technical front for area inspections with regulators and VIPs where required.

Extract and interpret batch/system performance data e.g., PCS, SAP, LMS,GLIMS to support investigations and batch deviations.

The role holder will also lead Major and Critical Deviation Investigations and be able to identify root cause. and establish and implement significant CAPAs.

Act as Manufacturing lead for Improvement Projects and department changes

Lead small improvement initiatives and use Business Improvement tools to identify and implement "proactive" improvements and contribute to delivery of cost reductions. Lead operational improvement projects.

The role holder will support the team leader in the daily running of the team and

• Plan the shift to deliver objectives i.e., resource planning, holiday cover, minimum manning levels maintained, reactive unplanned absence cover.

• Deputise for the Team leader for 1 or more shift blocks.       

• Regularly lead team meetings and allocate work and give feedback on performance.

• Enables and support the development of team members.

• Investigate and resolve routine inter-department issues.

• Assists in team development planning.

Qualifications:

Proven supervisory experience in pharmaceutical manufacturing preferred

Substantial experience in managing change controls and deviations within a highly regulated industry.

Preferable further education

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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