The QA Compliance team are looking for a Temporary QA Specialist (full time hours) reporting to the QA Compliance Manager. This is for up to one year assignment.
The successful candidate will assist and support the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. May perform internal and external audits.
Responsibilities
- Ensure batch records for biological drug substance are reviewed prior to Qualified Person (QP) certification
- Monitor compliance with the requirements of Good Manufacturing Practice (GMP)
- Review and assess the quality impact of any deviations prior to review and certification of product by QP or Quality Assurance (QA)
- Prepare Key Performance Indicator (KPI) information, including analysis of trends
- Participate in management reviews of process performance, product quality and of the Quality Management System (QMS) and advocating continual improvement
- Review and approve all documents within the scope of the QMS
- Assist in management of the self-inspection/internal audit system and its program, and conduct regular internal audits to assess compliance to EudraLex – Volume 4 – GMP guidelines and other applicable quality system requirements
- Prepare audit reports and raise non-compliance notices for areas which need improvement
- Assist in management of the internal nonconformance management systems specifically Corrective and Preventive Actions (CAPA’s), Deviations, and Supplier Corrective Action Requests
- Assist in Customer Complaint Handling, Reporting and closure of complaints
- Perform training on quality issues, when required
- Deliver Quality Induction training to new starters and perform Current Good Manufacturing Practice (cGMP) training to departments
- Act as a quality representative on projects
- Participate in Change Management, including the assessment of risk and impact
- Assist Purchasing with approval of suppliers and ongoing supplier management
- Perform external audits of suppliers, lab service providers, and contract manufacturers, as directed
- Coordinate and assist in customer audits
- Deputize for department management for approving quality documents when required including as a proxy signatory
- Review of batch records prior to release of other products not requiring QP certification
This job is fully qualified, career-oriented, journey-level position. Typically requires a scientific university degree and a minimum of 5 years of GMP related experience.
The successful candidate should
- Be able to operate independently on a day to day and project basis
- Be able to work across departments and with managers up to a senior level on quality related issues and projects
- Have excellent verbal and written communication skills with good attention to detail
- Be able to prioritize and organize own daily workload to meet agreed deadlines and support longer term projects
- Be computer literate in MS Office products and an ability to learn to use bespoke software systems
About us:
At Sekisui Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.
Equal Opportunities
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics, or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions. Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the Company’s internal recruiting team.