Associate Quality Assurance Specialist

Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Responsible for ensuring that the process for the manufacture of drug product at our Carlow site is in compliance with cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with the company's requirements to ensure compliance, safety and reliable supply to our customers. For Applicants, it is important to note that this will be a Shift IPT Role. The Shift pattern will be discussed in interview, as patterns of shift will differ at project stages/s. Principal Accountabilities: Documentation:   Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems. Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department. Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same. Support the development and implementation of improved quality reporting measures. Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process. ·       Quality Oversight: Work collaboratively to drive a safe and compliant culture in Carlow. Work shift patterns in line with manufacturing operations to ensure Quality oversight as required. Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations. Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained. Provide training in all aspects of Quality Management Systems and GMP Ensure all work is carried out in line with SOP’s, training or other quality systems such as change controls where applicable. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. Drive compliance with the company's Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems ·         Continuous Improvement: Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries etc.; thereby ensuring IPT is audit/inspection ready. Conduct area inspections for IPT as appropriate. Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same. Such ongoing monitoring/metrics gathering may include: Monitoring of quality systems The self-inspection program Verification of the effective implementation of key GMP programs Effectiveness of Preventative Actions Leadership activities including selection, development, coaching, and day to day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs. Required to comply with regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Requirements Skills and Knowledge Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site. GMP Audit experience in the pharmaceutical industry Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues and trends. Communication, decision making, people influencing, and project management skills will be important.  Report, standards, policy writing skills required. Demonstrated ability to make and act on decisions while balancing speed, quality and risk. Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights Education Third Level Degree qualified in a Science/Technical or related discipline. Requirements What you will do: Bring energy, knowledge, innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues, as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics Ensure the escalation of risks to management in a timely manner. What skills you will need: In order to excel in this role, you will more than likely have: 5 years’ experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control, Operations or Technical Operations within the Biological and/or pharmaceutical industry. Previous experience in SAP Master Data build and maintenance QMS development and maintenance. Previous experience in Deviations and Change Control, participating in investigations and problem solving. Strong attention to detail and precision in preparing and reviewing GMP documentation. Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar Strong written and verbal communication skills. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner. Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals. Desirable: Experience in direct interactions with regulatory agencies during site inspection.