Scientific Review Officer

Descripción del puesto:

Company Description:

Business Unit (COMPANY NAME) PROXY is part of the international operating (COMPANY NAME) Scientific and is a GMP Quality Control laboratory, where analytical chemical testing of raw materials, drug substances and drug products is performed. A large part of this work comprises routine compendial testing. However, for new products, formulations or monographs clients require development or validation of analytical methods.

Job Description:

As Scientific Review Officer at (COMPANY NAME) PROXY you are part of our Studies and Finished Products team. You will work in close collaboration with our Project Managers and Scientists, and you support them by reviewing their protocol and report documents. You are also responsible for upholding the quality standard and strife for further improvement of these documents.
Your main responsibilities are:
* Review of analytical protocols and reports (including analytical method validation, method feasibility, analytical method transfer, etc.);
* Ensure all work is performed according to GLP/GMP requirements and apply GLP/GMP in all areas of responsibility as appropriate;
* Ensure analytical study protocol and report is designed based on AQbD principles and regulatory requirements (GMP);
* Review of analytical method procedures and analytical development;
* Assisting in establishment of in-house SOP's;
* Take an active role in continuous improvement, identify and drive improvement initiatives in line with GMP and ICH guidelines;
* Support during internal and external audits;
* Any other specific functional activities defined on case to case basis.

Qualifications:

* You have a PH.D, MSc (with 2+ years of relevant experience) or BSc (with 5+ years of relevant experience) in analytical chemistry, biochemistry or organic chemistry;
* You have strong background in analytical science (chemistry);
* You have experience in validation of analytical methods, preferable in biotechnology or pharmaceutical industry;
* You are familiar with relevant ICH guidelines;
* You have experience with GMP;
* You have basic knowledge of AQbD;
* You enjoy working in a fast-paced environment and have excellent interpersonal skills;
* You are proficient in the use of business applications such as MS PowerPoint, MS Word and MS Excel;
* You demonstrate outstanding verbal and writing skills in English and a meticulous attention to detail.

Additional Information:

PROXY and (COMPANY NAME): A world of possibilities
This position is based at (COMPANY NAME) PROXY on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. (COMPANY NAME) PROXY also offers:
* A competitive salary;
* Flexible working hours;
* 25 days of vacation (with the option to purchase 7 additional days);
* Travel allowance. Do you travel by public transport? Then your travel costs will be fully reimbursed;
* Participation in a pension scheme with 50% contribution by (COMPANY NAME);
* 8% individual choice budget to use for extra salary, vacation days, extra pension accrual, and more;
* Discount on additional health insurance;
* A cycling and/or fitness scheme to promote vitality;
* Professional training and opportunities for training and development;
* Training options via the online learning platform Good Habitz.
Working at (COMPANY NAME) PROXY offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having (COMPANY NAME) as a parent company. Our ambitious growth plans provide ample opportunities for our employees:
* Diverse developmental opportunities within the organization;
* A large client portfolio ensures a lot of diversity in your work.
More about (COMPANY NAME) Scientific
(COMPANY NAME) Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, (COMPANY NAME) is one of the leading global emerging players in specialty clinical diagnostic testing.
In 2022, (COMPANY NAME) generated 6.72 billion Euro proforma turnover in 900 laboratories across 61 countries, employing about 62.000 staff.
Would you like to know more?
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Acquisition for this vacancy is not appreciated