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QC Manager - Pharmaceuticals
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Pharmaceutical organization, based in Basel-Landschaft Switzerland.
Our client is a producer of API's.
- Identification of gaps in compliance (e.g. from Audit findings, interpretation of recent and forthcoming guidelines).
- Development of policy solutions and/or justifications to address gaps in collaboration with a wide range of stakeholders. Comparison of different solutions based on cost/benefit/risk principles.
- Translation of developed policy solutions into practice (SOP writing, optimization of standard forms, change management, training, improving awareness)
- Identification of existing procedural deficiencies and training requirements, continuous improvement of same.
- Close collaboration with the Q-Unit Managers during identification of solutions and during change procedures .
- Reporting to Senior Head of Quality
- Close collaboration with Quality Assurance, Quality Systems and Regulatory Affairs. Analyzing and selling the value-add of QCA compliance activities to stakeholders at all levels.
- Has exceptional written and verbal communication skills and is able to communicate effectively across cultural and linguistic boundaries.
- Has the ability to negotiate and influence across and out with the organisation at all levels of management.
- Sound analytical background (ideal: small molecule API business, AD, QC) and profound knowledge of API GMP business including the related regulations and guidelines
- A high level of conceptual and strategic thinking is necessary. Must be able to combine systems analysis with creativity in problem-solving.
- Is able to co-ordinate and make best use of resources across all functions, able to manage others in a matrix manner without conflicting with line
- A high degree of independence and self-management is required. Must be able to co-ordinate and prioritize many activities simultaneously. Must be able to delegate effectively in support of overall workload of self and function.
- Fluent in English and German
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.