Review Specialist Gmp

il y a 1 mois


Leuven, Belgique Oxford Global Resources Temps plein

**Review specialist GMP**:

- Location:
Leuven
- Contact:
Thomas De Naegel
- Job type:
Temp to Perm
- Contact phone:
+32 15284045
- Industry:
Biotechnology

Are you interested in GMP legislation and QA?

**Function**

The Review Specialist position is responsible for handling pre-manufacturing reviews, post-manufacturing reviews and GMP administration. During review assignment, this position will ensure products are processed according to customer requirements before product release. During administration assignments, the position will coordinate document handling needed for compliance with ISO 13485, as well as daily operations in the GMP Manufacturing department

**Responsibilities**:

- Main focus will be onGMP review:

- Completes preliminary reviews of entered orders and specifications
- Makes independent decisions regarding a product's path based on individual attributes of the product and customer requirements
- Performs final manufacturing reviews: Identifies and investigates inconsistencies between requested specifications and final oligo specifications
- Reviews and documents procedures used for each product in custom software or by other controlled methods
- Makes pass/fail determinations based on QC testing and customer requirements
- Adheres to customer specifics (in a strict manner) as well as general work instructions and SOPs
- Troubleshoots and corrects inconsistencies and problems that may occur during daily operations
- Investigates customer complaints and obtains data for customer inquiries when necessary
- Assists in utilizing metrics to monitor and communicate TAT and error rate to lab and upper management
- Collaborates with members of team, as well as management, to ensure open communication and teamwork
- Additionally,GMP administration tasks can be performed:

- Identifies effectively, the need for documentation/process changes, process deviations, product non-conformances and other occurrences that can indicate the ineffectiveness of quality and/or manufacturing systems
- Creates work instructions, standard operating procedures (SOP) and oligo master records (OMR) that meet customer requirements
- Reviews current documents, proofreads others' new documents for accuracy, and makes necessary changes.
- Performs training on new procedures
- Performs controlled copy and internal reference document audits
- Coordinates audit preparedness activities
- Maintains GMP Mfg's websites (group and department SharePoint sites, CCM TechReview, etc).
- Initiates PCOs when necessary for process and instrument changes
- Participates in the validation of processes performed in the group
- Collaborate closely with QA department

**Profile**

**Education**:

- Degree in science related field plus 2 years of applicable lab experience preferred, or equivalent work experience

**Experience**:

- Proficiency in a variety of PC software programs with strong working knowledge of Microsoft Office (and an emphasis on Excel) required

**Skills**:

- Proficiency with Excel, PowerPivot, JMP, or other statistical analysis software preferred
- Proficiency with Word and PowerPoint preferred
- Ability to fluctuate priorities throughout the workday required

**Offer**
- Perm position in a growing, international company



  • Leuven, Belgique Science at Work Temps plein

    **Wat ga je doen?**: Onze klant te Leuven is op zoek naar een Reviewer. Deze persoon is verantwoordelijk voor de verificatie van uitgaande (GMP) klantenorders. De OVR Administrator voert deze taken uit en zorgt ervoor dat de procedures correct worden gevolgd. Takenpakket: - Uitvoeren van post-synthese verificatie op alle GMP orders (en geselecteerde...


  • Leuven, Belgique QAELUM Temps plein

    We are currently looking for a junior Quality Specialist for our HQ in Belgium. Qaelum NV is a fast-growing medical software solutions provider caring about patient safety, efficiency and quality improvements in medical imaging environments. With our solutions, we are one of the market leaders in Europe and have installations all over the globe. We believe...


  • Leuven, Belgique Terumo Europe Temps plein

    At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...


  • Leuven, Belgique Avantor Temps plein

    **Job Summary**: Avantor is looking for a **Senior Supplier Development Specialist** to join our team! This role will provide key analytics into current supplier performance and cost, and identify opportunities to improve overall performance into Avantor’s distribution network, reducing the cost of doing business with suppliers. This role is responsible...


  • Leuven, Belgique IMEC Inc. Temps plein

    Joint Communication and Sensing Specialist- Research & development - Leuven | Just now- - What you will doImec's Advanced RF program targets wireless communication systems above 100 GHz, offering breakthroughs in throughput, energy efficiency and reliability. This is possible thanks to the wide bandwidth and the easier integration of a large number of...

  • Talent Acquisition Specialist

    il y a 4 semaines


    Leuven, Belgique Twipe Mobile Temps plein

    As a Talent Acquisition Lead, you will be responsible for our recruitment strategy and implementation. Dare to make a difference and have an impact from Day One! **Your responsibilities** - Collaborate with different stakeholders to determine Twipe’s hiring needs. - Organise and follow-up the recruitment process from A to Z. - Continuously review our...

  • Software Architect

    il y a 1 mois


    Leuven, Belgique miDiagnostics Temps plein

    As our Software Architect, your responsibilities will include: - Defines software architectures, in line with high-level functional requirements; - Reviews and helps create functional requirements, test requirements, etc; - Defines the entire software technology stack (coding languages, interfaces); - Defines the coding guidelines; - Chairs architecture...

  • Junior Digital Marketer

    il y a 1 mois


    Leuven, Belgique GC Europe Temps plein

    We are strengthening our EMEA Marketing Communications team and are looking for a creative Junior Digital Marketer. You will work closely with our e-Marketing Specialist to assist in the planning, execution, and optimization of our online marketing efforts and campaigns across the EMEA region. **Junior Digital Marketer** **Main responsibilities**: Campaign...

  • Supply Chain Coordinator

    il y a 4 semaines


    Leuven, Belgique Medpace, Inc. Temps plein

    Job Summary: Our clinical operations activities are growing rapidly, and along with it our Supply Chain is growing more complex. We are currently seeking a full-time, Supply Chain Coordinator to join our Clinical Operations team. This position partners with cross functional teams to ensure seamless communication with vendors in support of on-time delivery to...


  • Leuven, Belgique IMEC Inc. Temps plein

    Program Coordinator of The Flanders Al Research Program- Business Operations - Leuven | Just now- What you will doAs Program coordinator of the Flanders AI Research Program, you support the successful execution of the program. You will work closely together with the program director, researchers and research leaders in the program. You will engage in the...

  • Supply Chain Coordinator

    il y a 4 semaines


    Leuven, Belgique Medpace, Inc. Temps plein

    Job Summary: Our clinical operations activities are growing rapidly, and along with it our Supply Chain is growing more complex. We are currently seeking a full-time, Supply Chain Coordinator to join our Clinical Operations team. This position partners with cross functional teams to ensure seamless communication with vendors in support of on-time delivery to...


  • Leuven, Belgique Catawiki Temps plein

    Who we are ,, - at Catawiki, we come across exceptional objects such as these every day. Catawiki is the leading online marketplace to buy and sell special objects. We offer over 75,000 special objects in auction every week — each reviewed and selected by one of Catawiki’s hundreds of in-house experts specialised in Art, Design, Jewellery, Fashion,...

  • Legal Counsel

    il y a 5 jours


    Leuven, Belgique imec Temps plein

    /Legal Counsel - R&D & Business Contracts Legal Counsel - R&D & Business Contracts Legal - Leuven | Just now As a legal specialist in contract drafting and negotiating, you support the imec group to ensure that imec’s growth is duly protected by concluding solid agreements. Legal Counsel - R&D & Business Contracts  What you will do You...


  • Leuven, Belgique AB InBev Temps plein

    At AB InBev, dreaming big is what we do. Brewing the world's most loved beers, building iconic brands like Bud, Stella Artois, Hoegaarden, Tripel Karmeliet, Leffe and crafting meaningful moments are what inspire us.We're a team of passionate owners who aren't afraid to dream big because we know that together, we can achieve anything. To build a...


  • Leuven, Belgique AB InBev Temps plein

    At AB InBev, dreaming big is what we do. Brewing the world's most loved beers, building iconic brands like Bud, Stella Artois, Hoegaarden, Tripel Karmeliet, Leffe and crafting meaningful moments are what inspire us.We're a team of passionate owners who aren't afraid to dream big because we know that together, we can achieve anything. To build a more...