• Supporting the manufacturing operations, ensuring readiness for batch initiation and progression, and performing batch review following batch manufacture.
• Ensuring adherence to all developed quality systems.
• Issue Batch Manufacturing Records, Logbooks and Worksheets to operational teams.
• Review and approve both clinical and non-clinical labels to support batch manufacturing activities.
• Review and approve Logbooks, support monthly Logbook Spot Checks and quarterly Logbook audits.
• Provide QA support to Labelling and Packaging activities.
• Perform review of completed batch records and associated documentation in a timely, efficient, and compliant way.
• Maintain a status tracker and provide accurate status reports on batch record review to support batch compilation activities.
• Support batch compilation and release duties in accordance with relevant procedures.
• Investigate and report quality issues, escalating to management as required.
• Provide quality assurance overview and review of shipment paperwork and provide QA oversight at shipment dispatch.
• Complete other activities as requested by Line Management to support Operational Quality Assurance and the wider Symbiosis business.
• Deal with post manufacture document review (BMRs) and supporting batch documentation, both reviewing and coordinating.
• Responsible for label approval.
• Perform QA review of shipment paperwork and provide QA oversight at shipment dispatch.
• Provide QA coaching/guidance as appropriate to knowledge and experience for cross-functional groups to ensure compliance.
• Support the organisation's environmental objectives and commitments under its ISO 14001 Environmental Management System. This includes complying with relevant environmental policies and procedures, contributing to sustainability initiatives, minimising environmental impact within my area of responsibility, and promoting environmentally responsible working practices.
• Support the organisation's health and safety objectives by complying with relevant health and safety policies, procedures and safe systems of work. This includes taking reasonable care of my own health and safety and that of others who may be affected by my actions, reporting hazards, incidents and near misses, contributing to risk reduction within my area of responsibility, and promoting safe and responsible working practices.
• Attend, participate and contribute to regular staff meetings as necessary.
• Invest in developing relationships with all staff to fully understand staff needs.
• Invest in developing relationships with the management team to ensure we are a high performing team and Symbiosis' services meet expectations.
• Act as an ambassador for the company.
QUALIFICATION
Essential -
• Educated to HND as a minimum in Life Sciences.
Desirable -
• Educated to degree level.
KNOWLEDGE
Essential -
• IT skills - Microsoft packages.
Desirable -
• Experience in Electronic Quality Management Systems.
EXPERIENCE
Essential -
• Experience in a GMP manufacturing environment.
Desirable -
• Experience in a service company and with a very strong client orientation.
SKILLS
Essential -
• Effective communication skills.
• Flexible and adaptive team player.
• Ability to perform multiple tasks effectively in a busy environment
• Effective planning and organisational skills
Please submit your details, CV and a covering message to apply for this role.