- Ref: LSQANCL
- Location: Newcastle Upon Tyne
- Sector: Pharmaceutical
- Contract: Permanent
CDM Life Science, recruiting on behalf of a leading pharmaceutical company committed to delivering high-quality, safe, and effective medicinal products to improve patient health and well-being are seeking a skilled and motivated Quality Assurance Specialist to join their dynamic team.
As a Quality Assurance Specialist, you will play a crucial role in ensuring the compliance of pharmaceutical products with regulatory standards and internal quality systems. You will be responsible for implementing and maintaining quality assurance processes, conducting audits, and collaborating with cross-functional teams to uphold our commitment to product quality and patient safety.
Quality Assurance Processes: Develop, implement, and maintain robust quality assurance processes in alignment with current Good Manufacturing Practices (cGMP) and company policies. Ensure adherence to applicable regulations and guidelines, including ICH, FDA, EMA, and other relevant authorities.
Document Control: Oversee the document control system to manage standard operating procedures (SOPs), quality manuals, and other critical quality documents. Review and approve changes to documents, ensuring accuracy and compliance.
Internal Audits: Plan and conduct internal audits of processes, systems, and facilities to assess compliance with quality standards. Prepare audit reports, identify areas for improvement, and collaborate with departments to address audit findings.
Supplier Quality Management: Evaluate and monitor the performance of suppliers and contract manufacturers through supplier audits and assessments. Review supplier documentation and certifications to ensure compliance with quality requirements.
Batch Record Review: Conduct thorough reviews of batch production and control records to verify compliance with established procedures and specifications. Release batches for distribution after confirming product quality.
Deviations and CAPA Management: Support the investigation of deviations and non-conformances, assisting in the determination of root causes and the implementation of corrective and preventive actions (CAPAs) to prevent recurrence.
Change Control: Review and approve change control requests related to processes, equipment, and systems to assess potential impacts on product quality and regulatory compliance.
Training and Compliance: Facilitate and support training programs related to quality systems and cGMP requirements, ensuring employees’ understanding and compliance with established procedures.
Quality Metrics and Reporting: Track and report on key quality metrics, analysing trends and providing insights to management. Assist in the preparation of quality reports for internal and regulatory purposes.
Continuous Improvement: Identify opportunities for process improvement and lead quality-related projects to enhance efficiency and effectiveness within the quality assurance department.
Qualifications and Requirements:
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.
Proven experience (typically 2-5 years) in quality assurance within the pharmaceutical industry, with a strong understanding of cGMP and regulatory requirements.
Knowledge of relevant regulations and guidelines, including ICH, FDA, EMA, and other global health authorities.
Experience in conducting internal audits and managing external supplier audits.
Detail-oriented with strong analytical and problem-solving skills.
Excellent communication and interpersonal abilities to collaborate effectively with cross-functional teams.
Ability to prioritise tasks, work independently, and meet deadlines in a fast-paced environment.
Proficiency in using quality management software and Microsoft Office applications.
Join our dedicated team and contribute to our mission of delivering high-quality pharmaceutical products that positively impact patients’ lives.
To apply or for more information contact Richard Hendry on 07525834272 or R.Hendry@cdmrecruitment.com
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