Talent.com
Orion Group
Senior Associate QA (GMP)Orion Group • Breda, North Brabant, Netherlands
Sollicitaties worden niet langer geaccepteerd
Senior Associate QA (GMP)

Senior Associate QA (GMP)

Orion Group • Breda, North Brabant, Netherlands
30+ dagen geleden
Functieomschrijving

Senior Associate QA (GMP) – Breda

Orion Group Life Sciences are currently recruiting a Senior Associate QA (GMP) on behalf of our Multinational Biopharmaceutical Client based in Breda, on an initial 12-month contract with potential to extend.

Shift Structure
Please note: This is a 3-shift position, following the rotation below:

  • Week 1 – Night Shift
  • Week 2 – Late Shift
  • Week 3 – Early Shift
  • Week 4 – Late Shift
  • Week 5 – Early Shift

Shift Times:

  • Early Shift: 06:30 – 15:00
  • Late Shift: 14:30 – 23:00
  • Night Shift: 22:30 – 07:00

Important: Please thoroughly discuss the shift structure with candidates. 100% commitment to the shift pattern is required.

Objectives & Responsibilities

  • Provide QA guidance and support within the production area at ABR.
  • Perform batch record reviews of batches assembled, packaged and labelled at ABR.
  • Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management, and the Qualified Person (QP).
  • Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures (SOPs) and Work Instructions.
  • Act as the first point of contact for quality-related production queries during packaging and labelling operations.
  • Review and approve batch production record data entries before production activities take place.
  • Perform finished product checks during commercial production runs.
  • Compile and review batch records for lots assembled, packaged and labelled at ABR in preparation for disposition by the QP.
  • Perform GMP compliance checks within production.
  • Review and approve deviation records.
  • Initiate and own QA deviations as required.
  • Act as an author for operational SOPs and Work Instructions, as required.
  • Review operational SOPs and Work Instructions, as required.
  • Assist in the development and delivery of GMP training activities for QA and Production staff.
  • Participate in QA production-related projects, as required.
  • Assist with various investigations, as required.
  • Assist with ABR projects and continuous improvement efforts, as required.
  • Prepare weekly and monthly metrics.
  • Own and maintain departmental performance boards.

Minimum Requirements

  • MSc or BSc degree in Pharmaceutical Sciences, Life Sciences, or a related field, or an equivalent combination of education and relevant experience.
  • Typically 3+ years of relevant Quality Assurance or manufacturing experience within the pharmaceutical or medical device industry, including experience with batch record review and investigations.
  • Knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/or Good Clinical Practice (GCP), with the ability to interpret and apply relevant requirements in mainly routine cases.
  • Experience with Manufacturing and/or Quality analytical processes and operations.




People are our business worldwide
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.



Maak een vacature-alert aan voor deze zoekopdracht

Senior Associate QA (GMP) • Breda, North Brabant, Netherlands

Vergelijkbare banen

Senior Test Automation Engineer: Accelerate Quality & CI/CD

ALTEN Nederlandcapelle aan den ijssel, zuid holland, Netherlands

A leading technology consulting firm in Capelle aan den IJssel is seeking a Senior Test Automation Engineer to enhance quality and reliability of software solutions.The ideal candidate will have a ... Laat meer zien

 • Gesponsord

Head of Quality – NH90 Program (Europe)

QabirdPapendrecht, The Netherlands

GKN Fokker Aerospace is seeking a Delegated Head of Quality to lead the NHI Quality function for the NH90 program, based on-site in Aix-en-Provence, France.Ligt uw cv klaar? Zo ja, en bent u ervan ... Laat meer zien

 • Gesponsord

Head of Documentation and Enablement

Wolters Kluweralphen aan den rijn, zuid holland, Netherlands

About the Role /h3pWe are seeking a forward-thinking and hands-on leader to head our Documentation and Enablement team.This team plays a critical role in empowering deployment teams, professional s... Laat meer zien

 • Gesponsord

Senior reporting consultant

Recruit Bridgegouda, zuid holland, Netherlands

Job description /h3pAs a reporting consultant you will mainly focus on advising, training and supporting our customers.By supporting our customers in using the application or by creating customer‑s... Laat meer zien

 • Gesponsord

Senior Manufacturing Engineer Product

GKN AerospacePapendrecht, The Netherlands

GKN Aerospace is reimagining air travel: going further, faster and greener! Fuelled by great people whose expertise and creativity sets the standards in our industry, we’re inspired by the opportun... Laat meer zien

 • Gesponsord

Senior Director, Quality

Repligen CorporationBreda, The Netherlands

Alle kandidaten dienen de volgende functieomschrijving en informatie zorgvuldig te lezen alvorens te solliciteren.Make a global impact—join Repligen.We’re united by a mission to inspire advances in... Laat meer zien

 • Gesponsord

Associate Director of Sales – EMEA (Drug Product Services)

LonzaBreda, The Netherlands

Lees de volgende functieomschrijving zorgvuldig door om er zeker van te zijn dat u de geschikte kandidaat bent voor deze rol voordat u solliciteert.DPS – EMEA Sales Associate Director.Belgium, Fran... Laat meer zien

 • Gesponsord

GMP CQV Engineer — Remote Validation & Commissioning Specialist

Talentmarkbreda, noord brabant, Netherlands
Op afstand

A leading engineering firm is seeking a Commissioning Qualification Validation Engineer in Breda, Netherlands.This role requires hands-on experience in commissioning and qualification within second... Laat meer zien

 • Gesponsord

Senior Project Engineer

NewColdBreda, The Netherlands

NewCold is service provider in cold chain logistics with a focus on the development and operation of large, highly automated cold stores.NewCold strives to be crucial in the cold chain of leading f... Laat meer zien

 • Gesponsord

Delegated Head of Quality (NH90 Program)

GKN AerospacePapendrecht, The Netherlands

GKN Aerospace is reimagining air travel: going further, faster and greener! Fuelled by great people whose expertise and creativity sets the standards in our industry, we’re inspired by the opportun... Laat meer zien

 • Gesponsord

Head of Quality, NH90 Program (Delegated)

GKN AerospacePapendrecht, The Netherlands

GKN Fokker Aerospace is seeking a Delegated Head of Quality to join NHIndustries (NHI) in Aix-en-Provence, France.Ligt uw cv klaar? Zo ja, en bent u ervan overtuigd dat dit de functie voor u is, zo... Laat meer zien

 • Gesponsord

Senior Process Improvement Engineer

SIRE® Life Sciences?breda, noord brabant, Netherlands

Consultant | Partnering with Global Leaders in Pharma, Biotech, Food, Chemical MedTech Industries | Driving Talent Solutions in Life Sciences… /h3 pbThe Company /b /p pOur client is one of the... Laat meer zien

 • Gesponsord

Senior Process Improvement Engineer — Lean Six Sigma (GMP)

SIRE® Life Sciences?breda, noord brabant, Netherlands

A leading biotechnology firm located in Breda is seeking a Senior Process Improvement Engineer to drive operational excellence.In this role, you will analyze manufacturing performance, lead LEAN an... Laat meer zien

 • Gesponsord

Intern Communication & Change Management – AIDA Program

QabirdKinderdijk, The Netherlands

Royal IHC is looking for an intern Communication & Change Management who can support the adoption of AI, Data and Automation across the organization.You will work at the heart of the AIDA Progr... Laat meer zien

 • Gesponsord

Director of Documentation & Enablement

QabirdAlphen aan den Rijn, The Netherlands

A leading technology firm in the Netherlands is seeking a Head of Documentation and Enablement to lead a multidisciplinary team.De onderstaande informatie behandelt de functie-eisen, de verwachte e... Laat meer zien

 • Gesponsord

M&A Investment Associate — Growth & Ownership

Blinqxbarendrecht, zuid holland, Netherlands

Een snelgroeiende PE-backed organisatie in Barendrecht zoekt een Investment Associate die het MA-proces ondersteunt.Je bent verantwoordelijk voor het beoordelen van kansen en het coördineren van du... Laat meer zien

 • Gesponsord

Global Quality Director, Bioprocessing

Repligen CorporationBreda, The Netherlands

Repligen Corporation is seeking a Senior Director, Quality, based in Breda, Netherlands, to lead the global Chromatography network, ensuring quality and compliance across all operations.You will de... Laat meer zien

 • Gesponsord

Regional Validation Engineer - GNSS & Machine Control

Trimble Inc.bodegraven, zuid holland, Netherlands

Caterpillar Trimble Control Technologies (CTCT) is seeking a Regional Validation Specialist to join an international team delivering verification and validation for CTCT products.You will work clos... Laat meer zien

 • Gesponsord

Senior Project Engineer (working US hours 1 PM - 9 PM)

NewColdBreda, The Netherlands

Ervaring, kwalificaties en soft skills: heeft u alles in huis om te slagen in deze functie? Ontdek het hieronder.To support our worldwide growth, we are looking to recruit an experienced Project En... Laat meer zien

 • Gesponsord

Senior Lead Engineer - Heavy Lift & Global Projects

MammoetBreda, The Netherlands

A dynamic international engineering firm based in Breda is seeking a Lead Engineer to lead technical engineering projects.Controleer hieronder of u heeft wat nodig is voor deze functie en, zo ja, s... Laat meer zien