Qualified Person (QP)

Orion Group Life Sciences are currently recruiting a Qualified Person on behalf of our Multinational Medical Device client based in Cork on an initial 12 - month contract (Onsite)

Role: Qualified Person (QP) Biopharmaceutical

Responsibilities:

• Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
• Certifies batches for sale or supply in compliance with regulations.
• Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
• Attends and participates Event Review, Quality Systems Review and Site QP Meetings.
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis to enforce requirements and meet specifications.
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
• May assist or lead compliance audits as required.
• May interface with regulatory agencies as required. Interfaces with contract manufacturers to address documentation and compliance issues.

Knowledge, Experience and Skills:

• Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge with good proficiency in Microsoft Office applications.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
• Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
• Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
• Some years of relevant experience in the pharmaceutical industry and a BS or BA or relevant experience and a MS.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.