QC Senior Compliance Specialist
The Role
Our client, a well-established company within the biopharmaceutical manufacturing sector, is seeking an experienced QC Senior Compliance Specialist to join their Quality Control Analytics team.
This is an excellent opportunity for a QC or QA professional with strong GMP experience to take on a key role supporting QC compliance, quality systems and timely product release within a highly regulated environment.
Key Responsibilities
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Review and approve QC documentation to support timely batch release and ensure GMP compliance.
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Coordinate stability records and support timely product release.
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Track and support OOS and quality investigations, ensuring timely closure.
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Create, track and report QC KPIs and quality metrics.
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Support the management of Deviations, CAPAs and Change Controls, ensuring completion within required timelines.
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Manage periodic reviews of QC documentation.
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Generate Statements of Testing (SOTs) and Certificates of Analysis (CoAs) to support batch release.
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Conduct area inspections within QC and support ongoing GMP compliance.
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Coordinate GMP training activities within the QC team.
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Support continuous improvement initiatives and promote a strong Right First Time culture.
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Ensure compliance with GMP, GDP and Data Integrity requirements.
The Ideal Candidate
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Degree in a scientific discipline or equivalent.
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Minimum 4 years' experience in a GMP-regulated QC or QA environment.
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Experience reviewing and approving batch records and quality documentation.
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Experience with Deviations, CAPAs, Change Controls and OOS investigations.
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Strong understanding of GMP, GDP and Data Integrity.
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Excellent attention to detail and strong organisational and problem-solving skills.
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Effective written and verbal communication skills.
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Proficient in Microsoft Office, particularly Excel, Word and PowerPoint.
Apply Today
If you are an experienced QC or QA professional looking for your next career opportunity, I would be delighted to hear from you.
