Senior Technician Quality Control

Orion Group Life Sciences are currently recruiting a Senior Technician Quality Control on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend

2 cycle shift pattern/as required by business needs, 20% shift premium
 
Bring energy, knowledge, innovation to carry out the following: 
 

• Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
• Ensure data integrity principles: ALCOA principals 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 products.
• Work collaboratively to ensure a safe and compliant culture on site.
• 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 products 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.
• 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.
• 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.
• Review of all 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.

 
 What skills you will need: 

• Degree in Science, Engineering or similar
• 2-4 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
• Lean Six Sigma Yellow Belt or suitable alternative
• Knowledge of cGMP in Laboratory Quality Systems.
• Proficiency in Microsoft Office and job-related computer applications required
• Demonstrated experience in Report, standards, policy writing
• Understanding of Lean Six Sigma Methodology preferred.
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
• Good communication, interpersonal skills and ability to work across teams.

 


People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.