Validation Improvement Officer - Montrose
CK Science is recruiting for a Validation Improvement Officer to join a company in the pharmaceutical industry at their site based in Montrose on a contract basis initially for 12 months.
Our Client: Our client is a global healthcare company who take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
The Location: The site is a is a 45-acre primary manufacturing site by the sea with over 300 permanent staff on-site. At this site Active Pharmaceutical Ingredients are converted into tablets, creams, and inhalers used for the treatment of Asthma, Eczema, AIDS / HIV, Influenza, high blood pressure plus more. The site is situated 38 miles north of Dundee between the mouths of the North and South Esk rivers.
The Role: To help maintain and further develop the capabilities of the site, our client is seeking Validation and Improvement Officers to join the Technical Development Validation team. Reporting to the site Validation Leader and working alongside a team of experienced professionals you will perform validation and associated improvement activities in a lean and effective way.
In this role your responsibilities will include:
- Ensuring site activities associated with validation are in compliance with quality management system requirements, including with relevant GMP requirements e.g. EU GMP, US GMP, Japanese GMP.
- Deputising for the Technical Development Leaders as directed.
- Participating in all aspects of validation activities for the site as directed by the Technical Development Leaders.
- Working in line with department and site requirements, including site KPI's and standard work activities, as directed by the Technical Development Leaders.
- Participating in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness.
- Participating in audits and inspections as required.
- Supporting day-to-day activities associated with maintaining QMS compliance, especially in the area of validation.
- Managing daily operational activities with a positive and proactive 'zero overdue' culture.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree level in a scientific or engineering field with demonstrable experience in the application of quality/compliance principals.
- Analytical ability to diagnose situations and develop solutions.
- Experience working in the pharmaceutical industry is essential.
- Experience working with APIs would be advantageous.
- Experience within validation is not essential, although it would be advantageous.
The successful applicant will be a strong communicator with the ability to support multiple departments across the site to ensure that day-to-day and routine validation challenges are resolved in a compliant, effective and timely manner and where necessary significant validation issues are escalated through the appropriate management lines and/or management processes.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43596 in all correspondence.