QC Tech – Carlow – Shift

Desired Skills: capa,quality,microbiology

PE Global is currently recruiting QC Technician – Micro on behalf of our client based in Carlow:

11 month initial contract- with 20% Shift Premium – 2 shift patterns

• Performs QC assignments for Carlow quality systems, processes and controls.
• Accountable for contribution to ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety & reliable customer supply.
• Responds to Operational and business areas, ensuring compliance with cGMP and corporate regulations.
• Support the performance of the site cGMP activities.

Responsibilities:

• Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable CGMP training.
• Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of human health products.
• Work collaboratively to ensure 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.

Responsible for activities including some or all of the following and any other tasks as required:

• Liaise with the Quality/ Business Area Specialists/QC Leads) to resolve quality related queries where required.
• Ensure that adequate processes and procedures are in place and followed for all Quality activities.
• Where required work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and or oversight) as required as per business needs & if needed.
• Provide support to the relevant support functions to ensure manufacturing and release of vaccine and biologic prodcuts activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing,, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Support business critical projects related to the Quality Department.
• Responds to standard requests and communication processes to allow the flow of appropriate information between departments.
• Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
• Support in resolving routine potential quality issues.
• Provide quality support of controls and procedures for the end to end material and product lifecycle where required.
• Perform laboratory testing and / or materials inspections to determine specification conformance.
• Perform all required analytical, microbiological and control testing to support the site.
• Maintain an adequate, qualified and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements.

Compliance Responsibilities

• Execute/Review /Support deviation/ CAPA activities, complaints, data integrity, Material Qualification, Validation, Quality Risk Management processes and other documentation including generation, investigation, documentation, implementation, verification closure, effectiveness and supporting trending where required for the Quality department and supporting functions.
• Ensure compliance to regulatory requirements.
• Review of all manufacturing batch/ material documentation including (but not limited to) electronic batch records, real time reports, master data using the Quality (Control) systems where required.
• Review of, SOP’s, GMP data and other documents as necessary for the Quality department where required
• Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.
• Participate in training programs & provide training to other team members as required.
• Support internal and external audits and inspections, ensuring department compliance/readiness.
• Provide quality support to the qualification/validation, technical transfers and commercial operations at the facility where required.
• Applies knowledge and skills to other areas within product/ department; may act as a source of technical expertise for others.
• Identifies and solves problems.

Educational and Experience Requirements

• Bachelors Degree or higher preferred; ideally in a related Science discipline
• 2- 5 years relevant experience

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***