- Quality Operations Biotech (around 100 people) is responsible for ensuring that our Manufacturing Division manufactures, tests and releases Biological Drug Substances and Bulk Drug Products in accordance to applicable local and international regulations.
- To this end the various Quality departments actively collaborate and set standards for all other Integrated Process Teams (IPTs) and CoEs (Center of Excellences) of our Manufacturing Division as well as regularly interact with other Manufacturing Division sites.
- Reporting into the Quality Control Lead, the GLIMS and SAP Lab Administrator will be responsible for Laboratory LIMS and SAP (Lab Master Data) as a System Administrator guaranteeing they are in full compliance with quality procedures,company’s PGPs, regulatory guidelines, and market authorization.
- Responsible for the validation and accuracy of data additions and changes into the LIMS and SAP systems and will support the laboratory in terms of project management, system validation and interdepartmental liaison, among others.
- Utilize LIMS and SAP knowledge, laboratory processes knowledge and SOPs to correctly maintain master data and to collaborate with other processes.
- Communicate and interact with Quality and others process teams, stakeholders and customer to resolve issues related to LIMS and SAP master data.
Input in Quality Strategy
- Complete LIMS and SAP Master Data changes regarding laboratory fields;
- Create, update, and retire LIMS records such as Item Code, Product, Suppliers, Units, Folders, Stability Protocol Templates, Sampling points, COA templates, Product Family, Storage Locations, User locations, Stability Trends among others;
- Maintain LIMS and Laboratory SAP data accurate and up-to-date;
- Recommend measures to improve procedures and get involved in the implementation of these measures;
- Support regulatory/ compliance audits such as, those performed by the FDA and/or any regulatory agency and facilitate the retrieval of Laboratory information as required;
- Assure that the laboratory LIMS and SAP systems are operating properly and in full compliance with cGMPs;
- Coordinate all system updates and changes to maximize effectiveness and efficiency on the laboratory and plant operations.
IPT activities in Compliance
- Ensure monitoring of the functional areas activities concerning compliance and take necessary action, in line with quality procedures and guidelines;
- Ensure that processes are in compliance with relevant regulations and company PGPs.
Guide the functional areas on system issues and ensure implementation of quality related improvements, procedures and guidelines.
- In co-operation with functional areas and in line with quality procedures and guidelines, support the handling of system deviations including implementation of CAPA’s.
- Administration and documentation
- Generate or review system SOPs;
- Generate, monitor, and ensure the implementation and administration of key performance indicators, and required GMP documentation (e.g. SOP’s);
- Understand and insight in the historic and current status of data and documentation of the system.
- Bachelor’s/ Master;s degree preferably in Science or Chemistry;
- At least five years of experiene in a laboratory of a pharmaceutical GMP environment;
- Experience with laboratory instrumentation;
- Knowledge of cGMPs, pharmacopeias, product specification, GLPs, and laboratory processes;
- Experience with laboratory investigations, LIMS, and SAP master data fields;
- Knowledge of and experience with quality and compliance guidelines and manufacturing processes;
- Ability to convert a quality mindset into practice and to bring others on that same page;
- Statistical knowledge;
- Advance computer skills on the use of Excel, SAP, and other required programs;
- Experience with SOPs Writing;
- Strong customer service skills (internal /external);
- Good oral and written communication skills in both Dutch and English.
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
A good place to work
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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