MSAT Technical Specialist
MSAT Technical Specialist
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Job Description
Are you looking for...
an exciting professional challenge
We are one of the leading European contract manufacturers in the pharmaceutical biotech and healthcare sectors with some 2500 employees in Germany France Finland UK and Norway. For us the next step is always the one that matters most. Our fast pace drives us forward fills our working environment with life and spurs our growth. Our winning formula for shared success: room for passion. Because we know that passion is the best medicine when it comes to excellent service around the world. Welcome to NextPharma.
Job Purpose:
This role reports to the QC department managers and will primarily perform maintenance calibration and qualification of analytical instruments and metrology equipment to ensure accuracy reliability and compliance with regulatory standards in accordance with agreed timelines. The ideal candidate will therefore have a pharmaceutical background and have ideally gained experience maintaining laboratory equipment within a cGMP FDA and MHRA regulated environment.
Key responsibilities and accountabilities:
- Collaborate with cross-functional teams to support analytical method development and validation
- Perform routine maintenance calibration and qualification of analytical instruments such as HPLC GC UV-Vis FTIR and balances with a strong understanding of metrology principles and practices
- Troubleshoot and resolve issues related to instrumentation and metrology equipment.
- Write (where applicable) and execute qualification protocols including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ)
- Provide technical expertise and training to laboratory personnel on the proper use and maintenance of analytical instruments
- Maintain accurate records of all maintenance calibration and qualification activities and work to defined equipment maintenance and qualification schedule
- Primary contact for third party vendors who support equipment qualification maintenance and repair including maintenance of service contract
- Comply with company health and safety procedures
Person Profile: Technical Support Scientist/Specialist
Personality:
Results oriented with a positive outlook and clear focus on high quality output. Attention to detail Precision in performing maintenance and calibration tasks with accurate record-keeping and documentation skills.
Solid planning and organizational ability with the a ability to prioritize tasks and manage time effectively; Reliable tolerant and dependable: Comfortable dealing with senior managers and customers: Enjoy working in a fast stimulating environment. Goal-oriented: Able to work under pressure and meet deadlines; Excellent communication/ presentation skills. Able to get on with others and be a team player but equally comfortable working independently.
Personal Situation
Flexible and able to work extended hours when required.
Specific Job Skills:
Required:
- Relevant qualification HNC/HND/Science Degree or Equivalent
- An understanding of drug development and manufacturing processes
- 3 years of experience in maintaining and qualifying analytical instruments
- Strong understanding of metrology principles and analytical instrumentation technologies
- Skilled in analytical techniques e.g. HPLC Dissolution Gas Chromatography and wet chemistry techniques
- Excellent problem-solving skills and attention to detail
- Able to communicate well with others both laboratory and non-laboratory based
- Able to work with minimal supervision.
- Good understanding of quality control SOP and GMP adherence
- Able to communicate well with others both laboratory and non-laboratory based
- Able to work with minimal supervision.
- Familiarity with regulatory requirements and industry standards (e.g. FDA regulations GMP guidelines)
Desired:
- Have a broad knowledge with and experience of working within a cGMP/GLP environment.
- Experience of working within a pharmaceutical or biotechnology industry
- Ability to work to key regulatory and compliance requirements
- Experience of chromatographic data package Chromeleon UV vison security FTIR Lab Solutions and Karl Fisher Tiamo software
- Experience of data reporting and checking data within a GMP environment
- Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.
Computer skills: Must be competent in the use of MS Office particularly Excel and Word
e-mail and internet. Previous use of chromatographic acquisition software is desired but not essential.
Literacy and Numeracy: Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.
Business Presentation Skills: Must be an excellent face-to-face and telephone communicator.
Management Skills: Must be skilled in leading/ training/guiding/mentoring others
Its time for your next chapter:
We look forward to receiving your application.
Required Experience:
Unclear Seniority
Employment Type
Full Time
