Job Description
A Qualified Person (QP) is sought to ensure quality and regulatory compliance in a next-generation manufacturing facility. The QP will lead quality initiatives, monitor GMP compliance, review and approve documents, and support regulatory submissions. The ideal candidate has 10 years of quality assurance experience in a biotechnology or pharmaceutical environment, strong knowledge of cGMP, and excellent communication skills.
Key Responsibilities:
* Technical Leadership: Provide quality leadership, direction, and governance; maintain knowledge and experience in line with scientific progress; communicate and educate personnel in GMP requirements.
* Quality Monitoring Programs: Monitor GMP compliance; verify effective implementation of key GMP programs and systems.
* Document Review/Approval: Approve quality-related documents; review and approval of change controls, deviations, and other GMP documents.
* Regulatory Submission & RTQ Support: Issue QP declarations; evaluate and contribute regulatory information to documents.
* Batch Approval: Ensure manufactured batches are certified in accordance with regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation.
Basic Qualifications:
* BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or related discipline.
* Approved by member state as a licensed QP.
Additional skills/experience:
* 10 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
* Strong understanding and working knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
* Demonstrated proficiency in planning, ability to work independently, and effectively communicate concepts to a wide range of personnel.