Qualified Person

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POSITION SUMMARY: This position is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice.

GENERAL SCOPE OF RESPONSIBILITIES:

• Responsible for certifying DSP batches prior to release to filling site

• Ensures that product manufacturing testing and release comply with applicable regulatory requirements and specifications prior to product release

• Maintains oversight of Quality issues and change controls ensuring that any issues that have a regulatory impact are notified to health authorities and mitigated as required

• Attends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required

• Maintains knowledge and understanding of quality oversight for services and operations which are outsourced to CMOs / contract test labs

• Maintains Qualified Person (QP) knowledge and experience up-to-date. If a new product type is introduced the QP must ensure that they have gained the relevant knowledge and experience necessary to complete QP duties.

• Maintains oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as required.

• Supports QA colleagues with product quality / license impact assessment for Quality Issues.

• Review and approval of Quality documentation associated with product manufacture.

KEY COMPETENCIES REQUIRED:

• Excellent interpersonal skills

• Management skills: Problem solving; statistical thinking; design of experiments

• Keeps up-to-date with the regulatory technical developments in the industry that will affect products on-site

• Excellent attention to detail

• Maintains focus on patients and customers at all times

• Maintains the highest standards of ethical behavior

QUALIFICATIONS AND EXPERIENCE (ESSENTIAL):

• At least 2 years relevant experience within regulated biologics / pharmaceutical industry and have fulfilled the educational requirements as outlined in Article 49 of Directive 2001/83/EC

• Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.

• Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.

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