We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,500 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 Development Analyst:
To conduct analysis, technical stability studies, development, validation and transfer of analytical methods. The role will be responsible for providing technical expertise at both a theoretical and practical level. The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment.
Key responsibilities and accountabilities:
Work as part of a team alongside other analytical departments.
Actively involved in performing analytical activities to determine fitness for purpose of finished products.
Conduct analysis to support formulation development.
Perform method development, validation and transfer analysis of analytical methods for Liquid Fill hard capsules.
Technically competent in analytical activities (e.g., method development and validation, HPLC, GC, Karl Fisher and Dissolution) Validation activities performed under current cGMP and ICH Q2.
Writing of development and validation protocols and reports.
Checking of analytical data.
Supporting good internal and external relationships and communication.
Comply with company health and safety procedures.
Person Profile: Development Analyst
Personality:
Results oriented with a positive outlook and clear focus on high quality output; Solid planning and organizational ability; Reliable, tolerant and dependable; Enjoy working in a stimulating environment; Comfortable dealing with peers and customers; 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 is equally comfortable working independently. Personal Situation:
Flexible and able to work extended hours when required. Specific Job Skills: Required: An understanding of drug development and manufacturing processes. Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards. Skilled in analytical techniques e.g., HPLC, Dissolution, Gas Chromatography, and Karl Fisher techniques. Able to communicate well with others, both laboratory and non-laboratory based. Able to work with minimal supervision. Good understanding of working within cGMP/GLP environment. Experience of working within a pharmaceutical or biotechnology industry. Minimum 2 years previous relevant experience in similar environment. Ability to work to key regulatory and compliance requirements. Experience of the technical and practical skills involved in stability studies, method development, transfer and validation. Experience of Chromeleon software. Experience of chemical analysis within a pharmaceutical environment (with formulations of drug products for pre-clinical and clinical trials). Experience of data reporting and checking. Able to work with minimal supervision. Understand and demonstrate a pragmatic approach to problem solving with GMP constraints. Able to communicate well via written media with specific emphasis on report writing. It's time for your next chapter:
We look forward to receiving your application.
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Results oriented with a positive outlook and clear focus on high quality output; Solid planning and organizational ability; Reliable, tolerant and dependable; Enjoy working in a stimulating environment; Comfortable dealing with peers and customers; 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 is equally comfortable working independently. Personal Situation:
Flexible and able to work extended hours when required. Specific Job Skills: Required: An understanding of drug development and manufacturing processes. Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards. Skilled in analytical techniques e.g., HPLC, Dissolution, Gas Chromatography, and Karl Fisher techniques. Able to communicate well with others, both laboratory and non-laboratory based. Able to work with minimal supervision. Good understanding of working within cGMP/GLP environment. Experience of working within a pharmaceutical or biotechnology industry. Minimum 2 years previous relevant experience in similar environment. Ability to work to key regulatory and compliance requirements. Experience of the technical and practical skills involved in stability studies, method development, transfer and validation. Experience of Chromeleon software. Experience of chemical analysis within a pharmaceutical environment (with formulations of drug products for pre-clinical and clinical trials). Experience of data reporting and checking. Able to work with minimal supervision. Understand and demonstrate a pragmatic approach to problem solving with GMP constraints. Able to communicate well via written media with specific emphasis on report writing. It's time for your next chapter:
We look forward to receiving your application.
#J-18808-Ljbffr
