Responsibilities
* Coordinate, execute & document qualification & process studies and additional product programs where applicable.
* Respond to operational and business areas, ensuring compliance with cGMP & 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 cGMP 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
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