Website Ref: TPM04140
A biopharmaceutical company in Cork requires a Qualified Person.
- 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.
Qualifications & Experience:
- BS or BA or relevant experience and a MS.
- Some years of relevant experience in the pharmaceutical industry.
- 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.
To apply for this job email your details to patricia.arrue-elorza@Tandempm.ie.