Senior QC Analyst

Catalent Pharma Solutions; Dartford; On-site; GBP 35,000 - 55,000; Full time

Job summary

Join a dynamic team at a leading global company dedicated to improving patient health. As a Senior QC Analyst, you will play a crucial role in ensuring the quality of pharmaceutical products by performing essential analytical testing and supporting compliance with industry standards. This position offers a unique opportunity to work with innovative technologies in a collaborative environment, where your contributions will directly impact the lives of patients worldwide. If you are passionate about science and quality assurance and want to be part of a company that values your expertise, this is the perfect opportunity for you.

Qualifications

• Proven experience in laboratory operation in a cGXP environment.
• Ability to mentor and train junior staff in QC processes.

Responsibilities

• Perform analytical testing consistent with cGMP requirements.
• Drive implementation of 5S methodology in QC.
• Prepare and review SOPs and analytical test reports.

Skills

HPLC

Analytical Testing

Particle Size Analysis

Method Development

Data Integrity Compliance

Education

Science Graduate

Tools

Malvern Mastersizers

Sympatec

FTIR

Raman

DSC

Karl Fisher

Job description

At Catalent we share a common goal: to put patients first and help people around the world live better and healthier lives. Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. We need great people who share our passion for excellence and have the drive and determination to make a difference,positively impact the lives of millions of people across the globe.

Catalent is currently recruiting for a Senior QC Analyst to join the Dartford team. This facility specializes in particle size reduction technologies and integrated analytical services for the pharmaceutical industry.

Shift based role:

Early shift 6am - 2pm Monday-Friday

Late shift 1:30pm - 10pm Monday-Thursday, 1:30pm - 7pm Friday

Night shift 9pm - 7am Monday - Thursday

The Role:

• Perform analytical testing in an accurate, timely and efficient manner, consistent with cGMP requirements. Testing may include, but is not limited to, routine particle size analysis (Malvern Mastersizers, Sympatec), cleaning verification (HPLC), identification testing (FTIR and Raman), method development and validation (including particle size and cleanability assessments), DSC, Light microscopy, SEM, Moisture content (Karl Fisher), method optimisation and troubleshooting, technology transfer and pharmacopoeia analyses as appropriate.
• Drive implementation and maintenance of the 5S methodology in QC.
• Support the management of QC metrics.
• Act as a trainer to new members of the QC team, including providing explanation on the basic principles of operation with regards to analysis being performed.
• Keep up to date with industry/regulatory developments in relation to particle size technology.
• Have a good understanding of PSA / HPLC/ DSC analytical equipment and methods.
• Prepare and review Standard Operating Procedures (SOP’s), including corporate and departmental guidelines.
• Prepare, review and execute analytical test reports for submissions to clients or other departments. These include, but are not limited to, Statement of Results, Certificate of Analysis and Cleaning Certificates, Method Qualification/ Validation Protocols, Method Qualification/Validation Reports and Laboratory Technical Transfer Studies.
• Experience of GMP requirement with regard to laboratory activities including deviation, change control and laboratory investigation.
• Ensure compliance with data integrity requirements of laboratory equipment and software systems.

The Candidate:

• Science graduate or higher with proven experience of laboratory operation in a cGXP environment or extensive industry experience.
• Particle Size experience desirable
• Experience in HPLC: Empower, Trouble shooting of equipment, Method Development and Validation essential.
• Experience in QC Lab: Investigations, CAPA’s, Deviations, Writing SOP’s
• Ability to mentor and train junior staff

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.