Similar posts
Deputy QP, Biologics
- Permanent
- Good Manufacturing Practice (GMP)
- Netherlands
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting for a Deputy QP, Biologics to join a pharmaceutical organisation. This role is on a permanent basis and is located in Hoofddorp.
Responsibilities:
- Handle QA batch release planning of products weekly.
- Assist with technology transfers and process/analytical method validation actions from quality operations perspective when needed.
- Evaluate, prepare batch document for QP batch certification of clinical trial batches, as well as guarantee proper upkeep of product specification files to guarantee compliance with INDs and IMPDs.
- Prepare yearly product evaluations of biologics products.
- Collaborate with the quality systems manager to assist with the QA IT systems and serve as a back-up for QA IT systems actions.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a (bio-)chemistry, pharmacy or similar field.
- At least 5 years of experience in a pharmaceutical drug substance and/or drug product manufacturing field.
- Expertise on EU GMP, US CFRs.
- Computer literacy.
- Fluency in the English language.
- A tenure of at least 5 years.
- Familiarity working within a pharmaceutical, sterile manufacturing setting.
- Knowledge in manufacturing, regulatory, QA/QC, QA operation, etc.
- Acquaintance in preparing batch release, which involves batch documentation evaluation and preparing for batch certification.
- Prior involvement and expertise on cGMP, QC/QC and regulatory compliance such as US, EU and any other global agencies.
- Comprehension of API/DP pharmaceutical operations, QA/QC procedures and contract manufacturing.
- Comprehension of multifaceted change control procedures and engagement with regulatory affair procedures.
- Comprehension of regulatory proposal processes.
- Able to evaluate and examine and analyse technical documents and offer quality assessments on change controls, deviations and complaints.
- Acquaintance working with electronic document management, electronic training systems and Trackwise.
- Comprehension of risk assessment and risk management fundamentals/tools.
- Former involvement engaging with external parties.
- Experience interacting with external parties.
If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie at +41 615 687 995.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-AK2
#QACompliance
Related jobs
Highly Competitive
Basel, Switzerland
Proclinical is seeking a Sample Management Officer to join our client's team in Basel.
Highly Competitive
Neuchâtel, Switzerland
Proclinical is currently working alongside a pharmaceutical company to recruit for a QA Expert Fill and Finishing. This temporary contract position is based in Neuchatel, Switzerland.
Highly Competitive
Visp, Schweiz
Proclinical is currently working alongside a contract manufacturing organisation to recruit for a QC Analyst. This temporary contract position is based in Visp, Switzerland.
Highly Competitive
Collegeville, USA
Proclinical is working alongside a pharmaceutical company to recruit for a Quality R&D Lead for a temporary contract position based in Collegeville, Pennsylvania.
Highly Competitive
Solothurn, Switzerland
Proclinical is currently working alongside a contract manufacturing organisation to recruit for a Quality Control Associate. This temporary contract position is based in Solothurn, Switzerland.
Highly Competitive
King of Prussia, USA
Proclinical is working alongside a biotechnology company to recruit for a QC Environmental Monitoring Expert for a temporary contract based in King of Prussia, Pennsylvania.
Highly Competitive
Augsburg, Germany
Proclinical is seeking a Sr. Quality Management Research & Discovery Specialist to join a dynamic team in the medical devices sector.
Highly Competitive
Philadelphia, USA
Proclinical is working alongside a pharmaceutical company to recruit for a Quality Assurance Operations Specialist I. This temporary contract position is based in Philadelphia, Pennsylvania.
Highly Competitive
Visp, Schweiz
Proclinical is seeking a dedicated Scientist QC Raw Materials to join a team focused on quality control within the Primary Packaging and Raw Material sector.