QC Specialist / Специалист по контролю качества

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

The purpose of this position is to assume specific responsibilities related to describing and optimization of warehouse operations (receiving, storage and distribution of investigational medicinal products) and ancillary materials). The holder of this position is closely involved in clinical supply logistics operations including cool chain activities and demonstrates comprehensive understanding of the QC functions including relevant legislation, good practices, policies and SOPs. The holder of this position is demonstrates ability to identify and advice on quality control issues, gained through several years experience in QC within the health care environment. The position interacts with QA staff, warehouse personnel and clients.

Key Responsibilities:

• Shows detail oriented approach in reviewing documentation;
• Identifies quality issues and applies in-depth knowledge of relevant legislation:

1. Legislative and regulatory acts, methodology documentation for quality control of products,
2. Systems, methods and technical control of products quality.

• Keeps track of changes in the legislation;

• The order of submission and reviewing of complaints related to the quality of raw materials, intermediates, components, finished and dispatched products;
• Conducting investigations of issues raised during process of QC checks of materials;
• Analyze the reasons of defects and violations of the processes, deterioration in the quality of work, defects, PRs, develops proposals for developments of quality, as well as monitoring the implementation of the necessary responsibility for efficiency measures for the receiving, storage and shipment of products in accordance with the requirements;
• Provides QC checks of incoming materials and preparation of reports on compliance with the quality standards and specifications;
• In-process control at all stages of production (labeling /re-packaging) process, quality control and completeness of the finished product, as well as the storage of raw materials, intermediates, components and finished products in accordance with requirements;
• Organizes of random checks the quality of products, raw materials, components, quality and condition of the technological process, equipment and tools, as well as storage of products;
• Ensures that procedures related to QC are implemented;
• Completes all necessary forms and registers in accordance to local and global SOPs;
• Suggests and implements improvements to current systems and procedures;
• Works independently, organizes all aspects of own work, responds effectively and quickly to urgent situations;
• Establishes Key Performance Indicators and takes metrics;
• Prepares detailed internal reports;

Minimum Requirements/Qualifications:

• Pharmaceutical education- preferable
• At least 3 years practical experience in the pharmaceutical industry and in warehouse
• Extensive knowledge of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and thorough knowledge of local legislation
• Good knowledge of the clinical trial supply chain process
• Excellent communication and organizational skills
• Good knowledge of operation of Quality department
• Flexible and adoptable, with strong customer orientation skills.
• Experience in reviewing technical documentation for compliance with relevant legislation, practices and policies
• Ability to analyze quality problems and define solutions.
• Ability to work under pressure and to support others within the team.
• Intermediate knowledge of English

Benefits:

• annual bonus based on performance
• meal allowance
• corporate mobile communication
• voluntary Medical Insurance
• accident & life insurance, travel insurance