The main purpose of the role will be to:
· Develop, optimize and implement analytical methods, e.g., for purity-, stability-, content-, potential genotoxic impurity determinations.
· Write-up of analytical methods for implementation.
· Conduct of release, retest, stability studies, transfer and validation analyses.
· Prepare documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
· Interpret and document analytical data including results from method development, release, retest, validation, stability, and transfer.
· Write-up of analytical protocols and reports, e.g., for validation and stability studies.
Further responsibilities will include:
· Assurance of adequate maintenance and operation of analytical equipment according to GMP.
· Drafting and review of CoAs and/or Analytical results sheet.
· Drafting of SOPs, GUIs, TPLs, FRMs.
· Training of Laboratory personnel.
· Ensuring of cleanliness of laboratory and work space.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
· Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering with 2-4 years BS or 1-3 years MS.
· Ability to efficiently plan and effectively execute and document analytical experiments in a GMP-compliant pharmaceutical environment.
· Previous laboratory experience is essential
· Basic knowledge of GMP.
· Good knowledge of sample preparation, HPLC instrumentation and techniques.
· Basic knowledge of spectroscopic methods, e.g., UV/VIS, IR.
· Basic trouble-shooting skills for analytical analyses.
· Flexibility, good communication, time management and team-working skills.
· Ability to work independently and to take initiative.
· Life-long learning mindset.
· Proficient in English.
This is an excellent opportunity to join innovative biopharmaceutical company.
Please could you send any correspondence in English. Please quote reference 46966 in all correspondence.
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