Coordinate, execute & document qualification & process studies and additional product programs where applicable.
Respond to operational and business areas, ensuring compliance with c GMP & regulatory requirements Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance Generation, review and approval of process documentation.
Execution of development and qualification studies across commercial and non-commercial product.
Representing Technical Operations department at cross functional meetings.
Development and qualification of new processes.
Qualification of new equipment where appropriate.
Lead & support investigations and troubleshooting of process studies as required.
Technical support for commercial manufacturing.
Technical support for new product introduction.
Ensure compliance with the QMS, industry/company specific standards and regulations.
Demonstrate effective communication and interpersonal skills.
Proactively act to consistently improve personal knowledge and capability.
Demonstrate an awareness of own capabilities and development needs.
Lead & support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and tools.
Application of technical knowledge to enable authoring of technical documents and technical decision making.
Support audit readiness, including preparation of story boards, ensuring GMP compliant documents are available, presentation to auditors as required.
Work collaboratively to drive a safe and compliant culture in Carlow.
Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
May be required to perform other duties as assigned.
Accountable for contribution to ensure that objectives are effectively achieved, consistent with regulatory requirements.
Respond to Operational and business areas, ensuring compliance with c GMP and requirements Support continuous improvement by active participation in, and contribution to, projects and problem- solving including use of MPS processes and tools.
Ensure that adequate processes and procedures are in place and followed for all relevant process activities.
Support business critical projects related to the Technical Operations department.
Provide technical support for cross functional programs & investigations Skills: GMP Risk Assessment Audits QMS CQV