QA Specialist

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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