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Senior qc investigations analyst

Loughborough
Analyst
Posted: 6 June
Offer description

Kindeva Drug Delivery Our Work Matters: At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. Role Overview: We are seeking a highly skilled and detail-oriented Senior QC Investigations Analyst to join our Quality Control (QC) team. In this critical role, you will lead and manage a variety of laboratory investigations, ensuring compliance with Good Manufacturing Practice (GMP) and company quality standards. Apply your analytical expertise to identify root causes, drive effective corrective and preventive actions (CAPAs), and support continuous improvement in QC operations. Working across cross-functional teams to support calibration activities and ensuring Good Documentation Practices, you will represent the department and include managing the external customers and regulators. Key Responsibilities include, but are not limited to: Work to appropriate laboratory systems, standards and procedures, (e.g., data recording, labelling, investigation and calibration procedures). Complete analytical documentation including the input of results onto the LIMS system. Awareness of current regulatory standards as applicable to laboratory functions. Champion GMP / GLP standards and principles within the laboratory area. Provide support / technical expertise to resolve problems with analytical testing. Complete preliminary investigations. Complete full-scale investigations with minimal support. Review and issue GMP documentation where full training has been received. Develop an understanding of the tests carried out and their impact on the products / materials worked on. Oversee the maintenance and calibration of laboratory equipment. Support continuous improvement activities within own group. Participate as a team member for Group CI projects as appropriate. Communicate with auditors and general employee expectations during an audit. Create basic project plans to detail activities and proposed timelines for laboratory / function-based activities. Skills & Experience: Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. 3 years of experience in a QC laboratory environment, with a focus on investigations is preferable. Proven ability to conduct detailed scientific investigations. Strong understanding of GMP regulations, to follow the 10 rules of GMP. Previous experience working with GLP, Specifications and Test Methods Experience with analytical techniques such as HPLC, GC, UV-Vis, etc., is an advantage. Knowledge and application of current safety regulations (e.g., CoSHH) as applicable to laboratory functions. Computer literate, familiar with Microsoft Word and Excel. Key Capabilities: Good organisational, interpersonal, and time management skills. Strong attention to detail and problem-solving mindset. Enthusiastic, flexible, conscientious and proactive in approach. Take a positive approach to own training and development. Good decision-making and problem-solving skills. Strong verbal and numerical aptitude skills. Good communication skills. Strong team player with the ability to work independently. What we Offer: Attractive compensation package. Company pension scheme (up to 10% employer contribution). 25 days holiday per year (plus bank holidays) plus service days after 5 years. Company sick pay. Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family. Life assurance of four times life cover salary. Flexible working hours. Wellness programmes. Employee recognition program. Employee development. Free on-site parking. Discount and cashback at many retailers. Cycle to work scheme. Flu vaccinations. Employee referral scheme. Additional Information: Working Hours: 37.5hrs per week Location: Derby Road, Loughborough All applicants must be eligible to work in the UK. We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide. LI-AC1 Kindeva is an Equal Opportunity Employer Other details Pay Type Salary

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