Qualified Person IMPs

SUMMARY

Our client offering services in formulation development and clinical manufacture across all the main dosage forms is currently recruiting for a Qualified Person

RESPONSIBILITIES

As a Qualified Person reporting to the CEO your responsibilities will include:
• Responsible for Quality Assurance and release of Clinical Supplies (and Specials) for specific projects. Liaises with Business Development Director, Chief Operations Officer and Chief Science Officer.
• Perform Qualified Person certification.
• Keep up to date with current and proposed pharmaceutical regulations in the EU and USA.
• Monitor, trend and, if necessary, correct any Quality aspects pertaining to the CMC projects including responding to customer complaints and advise management on any GMP quality deficiencies as appropriate
• Authorise, or designate responsibility for the approval of Batch documentation/laboratory records prior to release to a client
• Assist in GMP training.
• Perform or manage supplier and sub contractor audits and monitor performance.
• Attend Quality Review Meetings

QUALIFICATIONS

Eligible as a Qualified Person in accordance with Directive 2004/27/EC for IMPs
Possessing a qualification in a life-science related subject

SKILLS & EXPERIENCE

• At least 3 years work experience practicing as a Qualified Person in a relevant manufacturing environment.
• Well versed in requirements of the EU CT Directive and its importance within a commercial or clinical manufacturing operation.
• Experience of working to MHRA & FDA standards
• Proven record of operating effectively in a Quality leadership role
• First hand experience of diverse dosage forms with particular expertise in sterile products manufacture is essential
• An enthusiastic professional who is passionate about Quality
• Has a good understanding of how CMC fits into the drug development process
• An authoritative and credible leader who is able to influence and win the respect of their peers, colleagues and clients.



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