Hours of work 08:00 - 16:30 Mon - Thu & 08:00 - 13:30 Fri (37.5hrs)
You will be working for one of the country’s leading providers into the medical device, nutraceutical and pharma industry which include: specialist blending and formulation, packing solutions, contract packaging, printing and manufacturing of products within cleanroom environments.
Based at Lancaster but will need to visit their Morecambe site
- Take ownership & responsibility of on-site laboratories, to manage lab processes & equipment process validations, maintenance, & calibrations as per agreed procedures
- Provide testing & technical support to the quality, product development & regulatory functions using techniques such as: FTIR, classic titration, Rheometry, & development of in house test methods
- Testing of materials & liquids using current test procedures both at goods receipt & prior to processing.
- Coordinate the testing of, & reading & reporting of CFU’s for clean room settle, contact, & air sampling plates on a weekly basis between external lab testing
- Coordinate the testing of, & reading and reporting of Particulate (Particle) count within Clean rooms.
- To manage the maintenance of the purified water unit, including performing monthly sanitisations & ordering of parts. To coordinate the sampling, of CFU’s for Purified Water Unit and Clean room washing areas & to read & report results as per test method
- To coordinate & complete the sampling, and carry out moisture and peroxide testing as per test method
- To manage, perform & report stability testing and extension of shelf life of chemicals
- Manage process & equipment, maintenance & calibrations as per agreed procedures
- To review all MSDS’s & maintain the Entropy database ensuring they are current & available for inspection
- To develop & maintain process documentation in line with ISO & customer requirements
- Create appropriate test methods for new products & blended liquids & ensure all information is recorded & updated
- Write or amend & validate their test methods to ensure that products & test equipment are being used & tested correctly to identify problems
- Assist with investigations of defective products after customer complaint & compliance matters (NCR’s), & suggest appropriate corrective actions ensuring results are recorded
- To monitor, log & record all production & warehouse area temperatures using Hobo system completely report to issue to customers
Essential
- In depth knowledge of QAM's
- Conversant with ISO/IEC 17025, ISO13485, or ISO 9001
- Auditing experience
- Organised, tidy, attention to detail & able to work in a methodical structure.
- Excellent Interpersonal & communication skills
- MS Office skills Excel, Outlook, & Word
- Good numerical skills & an understanding of statistics
- Audit trained/skills
- Full clean driving license
Desired not essential
- Experience within the Microbiological, Medical Device or Pharmaceutical industry
- GMP
- CAPA
- ECDL or equivalent