AGC Biologics A/S | Qualified Person (Delegated)

If you are a highly qualified and experienced QP, we invite you to apply for our opening at AGC Biologics. Join us in our mission to make a difference in the lives of patients worldwide.

Job Description:

As a QP (Delegate) at AGC Biologics you will play a pivotal role in ensuring the quality and compliance of our pharmaceutical operations. Your responsibilities will encompass the following key areas:

Responsibilities:

Batch Disposition: Take on the crucial responsibility of batch disposition to guarantee the quality and safety of our pharmaceutical products.

GMP Subject Matter Expert (SME): Serve as a GMP expert, providing guidance and expertise in Good Manufacturing Practices to support our manufacturing operations.

Regulatory / Compliance Support: Assist in regulatory and compliance activities to ensure adherence to industry regulations and standards.

Quality Decision Making: Collaborate with senior QA leadership to make informed QP decisions that drive continuous improvement and align with the concept of 'fitness for purpose.'

Shop Floor Presence: Maintain a strong presence on the shop floor, actively engaging with operational teams to enforce a culture of GMP excellence.

Cultural Development: Actively develop, mentor, train, and enforce a site GMP culture within Operations to foster a culture of quality and compliance.

Support for Regulatory Inspections: Provide support during regulatory inspections and contribute to the preparation for these critical events.

Audits: Conduct external and internal audits as necessary, including for-cause investigations and unscheduled cGMP audits. Provide support to management during third-party audits.

Profile:

• Attention to detail, critical thinking, analytical, and problem-solving skills.
• Strong decision-making skills and a 'can do' attitude.
• Ability to work in a fast-paced, matrix environment is essential.
• Capable of working to deadlines and prioritizing multiple tasks.
• Flexibility to meet changing business needs and priorities.
• Strong ability to work independently, manage one's time effectively, and ensure team members meet relevant department goals.
• Proven accuracy, reliability, and completeness in job accomplishment.

How to Apply:

Interested candidates are invited to submit their resume, cover letter, and relevant certifications via our career page.

AGC Biologics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

Qualifications:

Education: A minimum of an MSc in Industrial Pharmaceutical Science or a related course recognized by Regulatory Authorities to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.

Experience: Prior experience as a Delegated QP is essential. A minimum of 7 to 10 years' experience in the healthcare/pharmaceutical industry, gained in an FDA/EMA regulated and approved pharmaceutical environment, is required. Strong working knowledge of GMP principles and guidelines is necessary.

Expertise: Proficiency in one or more Pharmaceutical Operational areas, such as QA, QC, or Manufacturing, is preferred. Experience as a Delegate/QP in the biotech or pharmaceutical industry is essential.

Scientific Knowledge: Well-developed scientific knowledge in one or more areas of the knowledge areas defined in Article 49 of EU Directive 2001/83/EC. Knowledge of the principles of the manufacture of biological molecules, including upstream fermentation and downstream purification principles and techniques. Familiarity with the scientific principles of analytical techniques used for the analysis of the purity of manufactured biological products.