Quality Assurance Associate
- Cork
- Permanent
- Full-time
- Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready”
- Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities
- Act as a catalyst for change and improvement in performance/quality
- Provide an example of professionalism
- Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR
- Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured
- Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports
- Prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary
- Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits
- Periodic follow-up of ongoing deviations and Change Controls (PdAs) to assure timely closure of deviations and approval of PdAs, as appropriate
- Prepares SOPs, department IOPs, quality related reports and change control documents (PdAs) as required and appropriate
- Review process master documentation, revision of executed batch documentation and product specifications as required and appropriate
- Ensures that SOPs and IOPs are up to date, compliant and supports efficient production
- Review regulatory documentation and co-ordination of site documentation to support regulatory requirements
- Authorize the usage of production equipment/utilities when qualification required
- Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required
- Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate
- To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates
- To maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required.
- Accurately use and maintain all information systems
- Support the generation / reporting of KPIs for the team
- Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area
- Co-ordinate and assist with the analysis and investigation of customer complaints that may arise, ensuring all complaints are investigated and closed out within specified timeframes
- Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements, including those that have the potential to mitigate unnecessary complexity
- Apply and develop knowledge of Quality Assurance and participate in area processes, procedures and projects with the guidance of more senior colleagues
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Undertake any additional tasks commensurate with the role as and when required
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)
- Requires educational / training experience in a QA GMP environment within the Pharmaceutical Industry (desirable)
- Experience of working in a GMP operational environment (desirable)
- Training and experience of GMP standards (desirable)
- Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable)
- Knowledge of GMP practices
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package
- Good documentation skills and attention to detail
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down