SENIOR ANALYST IN QUALITY CONTROL

On behalf of our client Sinceritas, pharmaceutical company whose focus of operation is the cultivation and production of cannabis for medical purposes, DEKRA is looking for:

• SENIOR ANALYST IN QUALITY CONTROL

JOB DESCPRITION:

• Conduct HPLC or other instrumental analysis (GCMS or ICP or LCMSMS) of pharmaceutical samples to support research, development, and manufacturing activities;
• Develop and validate analytical methods for the quantification of active pharmaceutical ingredients (APIs), impurities, and degradation products;
• Perform routine analysis of stability samples to assess product quality and shelf-life;
• Troubleshoot instrument issues and optimize analytical methods for improved sensitivity, selectivity, and efficiency;
• Collaborate with cross-functional teams including R&D, Quality Control, and Manufacturing to ensure timely delivery of analytical results;
• Interpret chromatographic data accurately and effectively communicate results to stakeholders.
• Maintain laboratory instrumentation and adhere to regulatory compliance standards (e.g., cGMP, GLP, ISO);
• Train junior analysts on HPLC techniques, method development, and instrument operation;
• Participate in continuous improvement initiatives to enhance laboratory processes and productivity;
• Performs periodic calibrations, qualifications and prepares reports on performed activities. Develops instructions for working with instruments and laboratory equipment. Informs the department manager of any observed defects of the equipment in order to provide regular servicing and provide spare parts for it;
• Checks the safety standards and cleanliness of the laboratory;
• Trains new staff in QC for conducting laboratory procedures and analyzes;
• Follows pharmacopoeia and professional literature and in accordance with it suggests and makes selection and application of new knowledge in the field of quality control;
• Reports or investigates suspicious test results. Writes and documents performance reports outside the quality specification;
• Monitors results by parameters in specifications and prepares reports on out-of-trend results;
• Participates in and reviews internal assessments and audits where necessary;
• Prepares and checks certificates after completed quality control;
• Takes care of the reference library of standards, actively monitoring their use;
• Participates in the proper implementation of the Quality Management System and the environment and takes care of a clean and healthy environment;
• Other assigned responsibilities according to skills and qualifications.

QUALIFICATIONS:

• Bachelor’s degree in pharmacy, chemistry, or related field;
• Advanced degree (master’s, doctoral, specialist studies is considered an advantage);
• Minimum 5 years of work experience in a QC laboratory in pharmaceutical industry;
• Excellent knowledge of applicable analytical methods and procedures;
• Excellent knowledge of work processes in the pharmaceutical laboratory for quality control, GMP, DLP;
• Extensive experience in conducting various laboratory tests, working with HPLC, GCMS, ICPMS, LCMSMS etc;
• Ability for independent and teamwork with scientific and technical staff;
• Ability to work under minimal supervision and the ability to work flexibly based on changing priorities;
• Self-motivated, detail-oriented, and willing to accept additional responsibilities;
• Ability to think critically and possess problem-solving skills;
• Excellent interpersonal, verbal, and written communication skills;
• Good knowledge of written and spoken English.

ADDITIONAL INFORMATION

If you feel that you have the necessary experience and are interested in this opportunity, please send your CV in English on the following e-mail address: rabota.arbeit.mk@dekra.com

All received applications will be considered in strict confidentiality. Only short-listed candidates will be contacted for an interview.

 *By sending your CV and motivation letter, you agree that your personal data will be processed for the needs of recruitment and selection by DEKRA Arbeit Macedonia and they will be stored in the DEKRA database.
Note: Candidates can withdraw their permission to process their personal documents at any time by sending a notification to the e-mail: job.arbeit.mk@dekra.com