За компанијата: Предизвиците во областа на човечките ресурси не се само наша секојдневна работа, туку се и наша страст. Нашето знаење и експертиза ни дозволуваат да имаме уникатен пристап кон секоја задача. Нашите клиенти... повеќе за компанијата »
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:
- Implement, control and provide technical oversight of microbiological methods in the QC department
- Perform validation and regular microbiological testing and analysis of different matrices (plant material, processing media and any other samples) according to Ph.Eur, ISO and in-house methods of analysis of
- Receipt of materials, GPT, status labeling and evidence
- Input raw data in ERP software and evidence for material consumption
- Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state.
- Develop and write MOA and SOPs
- Contribution in investigations regarding out of specifications (OOS) results and address and manage deviations, change controls related to micro procedures.
- Work in compliance with written procedures (SOPs), fill in evidence, logbooks and all related GMP documents in a timely manner
- Perform microbial count testing and identification of microorganisms, record results and submit to responsible person
- Identification of pathogenic and other microorganisms, investigate origin and proposes treatments
- Review and propose changes to systems, procedures, methods, and submissions in relation with microbiological operations, as appropriate.
- Gather metric information for use in continuous improvement of areas of responsibility.
- Train staff on technical concepts and methods.
- Review laboratory data.
- Methods accreditation according to ISO 17025
- Prepare and review of SOPs, methods of analysis, protocols, and qualification / validation reports
- Monitor current GMP systems to ensure compliance with documented policies
- Develop and writes MOA and SOP
- Participate in ordering materials and equipment for MBL
- Control of qualifications, calibrations and validations
- Follow dates for requalification, recalibration, and revalidation
- Train new employees and monitoring
- Publish and interpret final results from MBL analysis
- Participate in an integrated management system
- Participate in a pharmaceutical quality system
- Perform other duties as assigned in accordance with employee’s qualifications.
- Bachelor's degree or advanced degree in Microbiology or related discipline;
- A minimum of 5 years’ experience working in a Microbiology laboratory, preferably in an pharmaceutical industry;
- The ideal candidate is well versed in various microbiological techniques and instruments;
- Strong knowledge of applicable methods to the testing of biopharmaceuticals;
- Working knowledge of quality systems and regulatory requirements;
- Strong knowledge of Quality Control processes, GMPs, and Microbiological method validation;
- Extensive experience in conducting laboratory investigations;
- Ability to communicate and work independently with scientific/technical personnel;
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities;
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description;
- Ability to think critically and demonstrate troubleshooting and problem-solving skills;
- Excellent interpersonal, verbal and written communication skills;
- Experience drafting qualification/validation protocols and reports. Experience executing equipment and method qualifications independently;
- Good command of written and spoken English;
- Microsoft office knowledge.
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: [најави се за да го видиш е-маилот]
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: [најави се за да го видиш е-маилот]