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Company Overview
The QC Analyst role is at a leading Pharmaceutical company in the North West of England. Our client has a wide portfolio of licensed and non-licensed products. The site has significantly expanded over the years to increase production capacity and is now looking to recruit Quality Analysts to support this expansion.
Senior QC Analyst Responsibilities:
1. Conduct routine and non-routine analysis of finished pharmaceutical products using techniques such as HPLC (High-Performance Liquid Chromatography) in compliance with GMP (Good Manufacturing Practices) guidelines.
2. Perform method validation and transfer activities, ensuring all analytical methods meet regulatory and quality requirements.
3. Maintain accurate and detailed records of all analytical activities in laboratory notebooks and electronic systems to ensure data integrity and traceability.
4. Analyse and interpret analytical data, identify trends, deviations, and potential issues. Report and investigate any out-of-specification (OOS) results according to company procedures.
5. Participate in laboratory investigations and CAPA (Corrective and Preventive Action) processes to ensure continuous improvement and compliance.
6. Support the development, validation, and implementation of new analytical methods and techniques to enhance laboratory capabilities and efficiency.
7. Collaborate with cross-functional teams, including R&D, Production, and Quality Assurance, to ensure timely and effective resolution of quality issues and support product development initiatives.
8. Ensure compliance with all relevant regulatory requirements, including GMP, ICH (International Conference on Harmonisation), and FDA (Food and Drug Administration) guidelines.
Qualifications and Experience:
* Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field; a master's degree is preferred.
* Experience in a pharmaceutical QC laboratory, focusing on finished product testing.
* Proven experience with HPLC analysis.
* Method development and validation experience is beneficial.
* In-depth knowledge of quality requirements.
* Experience working in a GMP-compliant environment is preferred.
* Strong analytical skills, attention to detail, and ability to interpret complex data.
* Excellent written and verbal communication skills for documenting and reporting analytical findings.
* Proficiency in laboratory software and electronic data management systems.
* Ability to work independently and as part of a team with a proactive, solutions-oriented mindset.
Benefits:
* Competitive salary
* Opportunities for professional development and career advancement
* A collaborative and supportive work environment
* Contribution to meaningful projects impacting patient health and well-being
Application Process:
Interested candidates should apply if their skillset aligns with the position. The client will contact shortlisted candidates directly to discuss the opening in more detail.
Note: The client is unable to provide sponsorship.
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