Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the development and manufacture of pharmaceutical products, providing a complete service from early-stage feasibility to GMP clinical manufacture. Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.
Continued growth and investment into the business has led to the creation of exciting new job opportunities; in our new GMP Manufacturing headquarters in Beeston, Nottingham. Upperton Pharma Solutions is undergoing a period of significant expansion to meet international customer demand and offer a comprehensive drug development portfolio, so now is a great time to join our team.
Reporting to the Quality and Compliance Director this role will be responsible for leading the co-ordination and development of the company software applications, IT infrastructure and various cloud-based services through working with both internal and external partners to support the growth of the business and deliver a compliant IT platform for business-critical systems and processes.
Responsibilities
* Ensure compliance with the company quality systems, GMP requirements and all regulatory body requirements.
* Responsible for ensuring all computerised systems at Upperton remain in a qualified state in accordance with the validation/qualification schedule
* Responsible for ensuring that any new software or applicable equipment is assessed in accordance with internal procedures including data integrity risk assessments.
* Authoring, reviewing and approving validation test scripts to support software qualification
* Author, review and authorise (where applicable) documentation within the Quality Management System.
* Generate, provide QA input to, and approve production related change controls, deviations, corrective and preventative actions and qualification documentation as required.
* Conduct self-inspections (as required) of the Upperton processes to assure compliance to company policies and procedures.
* Responsible for the review and approval (as required) of calibration and validation documentation.
* Provide specialist computer system validation advice to internal stakeholders.
* Proactively promote a continuous improvement culture within the company.
* Maintain continuous personal development and maintain up to date knowledge with current and proposed pharmaceutical regulations.
Essential Skills and Experience
* Experience working in QA/IT/IS on a pharmaceutical manufacturing site with working knowledge of 21 CFR Part 11, EudraLex volume 4 Annex 11 and Good automated manufacturing practice (GAMP).
* Very good communication skills and demonstratable experience of working as part of cross functional teams.
* Experienced in working with cross functional teams to identify and implement changes and improvements within pharmaceutical manufacturing and warehousing environments.
* Must have excellent communication, influencing and troubleshooting skills.
* Ability to effectively contribute within a team environment and work on own initiative.
* Meticulous attention to detail.
* Excellent planning and organisational skills.
* Ability to work accurately under pressure and to meet deadlines.
Benefits
* 25 days holiday and your birthday off!
* Company contributory pension package
* Life insurance
* Private Medical Insurance through Vitality
* Internal and external training courses and professional development support
* Free onsite car parking
We know it is the little things that make every day special, so we also organise employee events for you to attend throughout the year, like our annual Christmas party, summer party and charity fund raising events.
#J-18808-Ljbffr