Barrington James
Job title:
QA Specialist
Company:
Barrington James
Job description
Job DescriptionAbout the ClientOur client is a leading specialist in oncology treatment with a global presence. They are at the forefront of innovative cancer therapies, dedicated to improving patient outcomes worldwide. With a commitment to research and development, they continuously strive to advance the field of oncology. Their extensive international network and collaborative approach enable them to provide cutting-edge solutions and maintain the highest standards of quality and compliance.Responsibilities
- Ensure all tasks adhere to company policies, cGMP, cGCPs, SOPs, regulatory standards, health and safety, and environmental guidelines.
- Provide support for root cause analysis of Quality Incidents, conduct risk assessments, and offer approvals as needed.
- Manage internal training programs across all GxP areas, including onboarding, ongoing, and refresher courses.
- Handle complaints from receipt through investigation and respond to customers.
- Manage and approve deviations and CAPAs (Corrective Action, Preventative Action).
- Review and approve change controls and related documentation to ensure compliance with regulatory GMP and GCP requirements.
- Conduct internal audits and participate in the external audit program.
- Support regulatory inspections.
- Assist in the approval process for suppliers and starting materials.
- Engage in continuous improvement activities related to the Quality Management System, including the preparation, issuance, and distribution of SOPs.
Experience
- Bachelor’s degree in a relevant scientific discipline with 2-5 years of experience in a Pharmaceutical Quality environment.
- Experience in peptide pharmaceutical production or other operational functions regulated by MHRA, FDA, or similar regulatory bodies.
- Proficient in risk management.
- Expertise in multiple quality systems, such as Document Control, deviations, Training, Auditing, QMS reporting, Change Management, OOS, and CAPA.
- Excellent verbal and written communication skills.
- Ability to influence staff across various departments to uphold Quality principles.
- Effective communication skills at all levels within the organization.
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Expected salary
Location
København
Job date
Wed, 17 Jul 2024 22:51:19 GMT
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