Biotechnology Quality Control Chief İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
DEVA has been operating since 1958 and is one of the pioneering pharmaceutical companies in Turkey. DEVA, having R&D in focus manufactures with international quality standards and currently exports products to other countries worldwide.
DEVA is seeking for a Biotechnology Quality Control Chief;
- Masters level degree and professional training with a strong background in Chemistry, Biochemistry, Biology or similar scientific qualification
- At least 3 years of experience in the biotech industry is desirable
- Experience with therapeutic proteins, including monoclonal antibodies is required
- GLP/GMP expertise is of advantage
- Experience in SOP writing, method transfer and method validation is of advantage
- Proficient in experimental design, technical problem solving and continuous improvement
- Highly organized and capable of running a number of projects in parallel
- Meticulous record keeping and organizational skills are critical
- Self-motivated, pro-active, responsible, strong analytical thinking, result-oriented and an excellent team player
- Excellent communication and negotiation skills in English are desired
- No military obligation for male candidates
JOB DESCRIPTION
- Raw material, in-process, environmental/utility, product release, and stability testing.
- Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
- Investigation of laboratory non-conformances (events, deviations, and invalid assays).
- Maintenance, calibration and qualification of laboratory instruments and equipment.
- Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
- Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
- Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
- Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
- Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
- Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Benzer İş İlanları
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