Senior Specialist QA

4 weken geleden

Amsterdam, Noord-Holland, Nederland Organon Voltijd

Job Description

For our Distribution & Supply Chain Quality team we are currently recruiting for the role of Senior Specialist QA / GDP

Purpose of the role

In this Senior Specialist QA/GDP position, you will handle the collaboration and relationship with our regional Third Party Logistic Service Providers (3PLs) in Belgium. You will be part of an international team of 4 colleagues and report to the Associate Director Quality Assurance – SC Hub Quality Team Lead.

Main responsibilities

  • Lead & Coordinate as the primary Quality oversight of the regional 3PL which includes:
    • Maintain Quality oversight and management of 3PL distribution complaints, change control, deviations and audits, including trending and continuous improvement initiatives;
    • Serve as primary quality point of contact, internally for 3PL inbound & outbound shipments and externally for 3PLs;
    • Establish and maintain GDP Quality systems related to the importation, storage, warehousing, and distribution activities delegated to the 3PL and ensure overall compliance to GDP and Company policies;
    • Assist with 3PL Transportation Lane Risk Assessment;
    • Collaborate with internal and external stakeholders to enhance Logistics providers, transportation lanes' performance by periodically reviewing and addressing internal and external KPIs, CAPA effectiveness, and audit findings.
  • Support with Quality Management of SC Hub:
    • Support with standardization and implementation of SC Hub QMS as driven by global initiatives;
    • Assist with the management of deviations, CAPAs and change control systems, competent authority inspections and quality metrics reporting, at the SC Hub;
    • Support the SC Hub Annual Internal Audit Schedule by leading self-inspections and reviewing self-inspection protocols and reports of team Lead Auditors;
    • Act as Back-up in SC Hub team;
    • Provide support with trainings and guidance in GDP elements and procedures, creating awareness and ensuring compliance with regulatory requirements and local procedures, including the Falsified Medicines Directive (EU 2016/161).

Your profile

  • Bachelor's degree in Pharmacy, Chemistry, (Micro-) Biology, Chemical Engineering or Supply Chain Management;
  • Minimum 3 years of expertise and broad experience in Quality Systems, Quality Assurance, and Quality Control, including solid knowledge of global GDP/GMP, regulatory requirements, and good documentation practices;
  • Exceptional problem-solving skills, based on science, facts, data, and understanding of the regulatory requirements in complex and evolving environments;
  • Demonstrated strong interpersonal, communication and ability to handle organizational complexity and ambiguity;
  • Good people/team collaboration experience;
  • Fluency in English (required) and good command of Dutch (preferred).

We offer

Join our truly global, dynamic and challenging environment with abundant opportunities for personal development. Our compensation and benefits package are highly competitive.

Secondary Job Description

Who We Are:

Organon provides innovative health solutions that empower individuals to live their fullest lives. As a $6.5 billion global healthcare company, we are devoted to making a significant impact for women, their families, and the communities they support. Focused on Women's Health, biosimilars, and a diverse portfolio of health solutions, we strive to enhance access and touch lives. Our Vision remains resolute: A better and healthier everyday for all women.

As an equal opportunity employer, we encourage applications from candidates with varied backgrounds. Committed to fostering an inclusive environment for all applicants.

If you need reasonable accommodation(s) during the application process, interviews, or other aspects of the employee selection process, please contact us.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

10%

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R523461

  • QA Specialist

    5 dagen geleden

    Amsterdam, Noord-Holland, Nederland CheckMark Labrecruitment Voltijd

    BedrijfsomschrijvingAn international pharmaceutical company in Amsterdam.You will be part of the Operations Quality and Compliancedepartment, which has a global focus.FunctieomschrijvingAs QA Specialist you will provide support of globalquality & compliance strategy for commercialized pharmaceuticalproducts with global or multiregional scope. Your...

  • QA Specialist

    2 maanden geleden

    Amsterdam, NH, Noord-Holland, Nederland CheckMark Labrecruitment Voltijd

    Goede beheersing van de Nederlandse taal in woord en geschrift is vereist voor deze functie. High level of the Dutch language in word and writing is required for this position.In this position as QA Specialist you play a crucial role in ensuring quality and compliance oversight to marketed global ph

  • Senior Associate QA

    3 weken geleden

    Amsterdam, Noord-Holland, Nederland Orion Group Voltijd

    Orion Group Life Sciences are looking for a Senior Associate QA (GMP) in 3 shifts, on behalf of our Multinational Pharmaceutical/Biotechnology client located in Breda. Initial 12-month contract, with high possibility of extension. Main Responsibilities of the roleTo provide QA guidance and support in the production area at ABR.To perform batch record review...

  • Senior Associate QA

    2 maanden geleden

    Amsterdam, Noord-Holland, Nederland Orion Group Voltijd

    Orion Group Life Sciences are looking for a Senior Associate QA (GMP) in 3 shifts, on behalf of our Multinational Pharmaceutical/Biotechnology client located in Breda. Initial 12-month contract, with high possibility of extension. Main Responsibilities of the roleTo provide QA guidance and support in the production area at ABR.To perform batch record review...

  • Senior QA Engineer

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Knab Voltijd

    Senior QA Engineer (Test Strategy/Automation) Knab was founded in 2 because we wanted to do things differently. Simpler, smarter and more advantageous for our customers. Because we believe we can help everyone maximize their financial affairs. "Feel at ease when it comes to your finances. Every day. By combining smart technical solutions with a healthy...

  • QA Coordinator

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Cosun Voltijd

    FunctieomschrijvingBen jij een enthousiaste professional met een passie voor kwaliteitsmanagement? Heb je ervaring in de voedingsindustrie en ben je klaar voor een nieuwe uitdaging? Dan zijn wij op zoek naar jou voor de functie van:QA CoördinatorWat ga je doen?Als QA Coördinator ben je verantwoordelijk voor het kwaliteitsmanagement voor onze...

  • QA Coordinator

    5 dagen geleden

    Amsterdam, Noord-Holland, Nederland Cosun Voltijd

    FunctieomschrijvingBen jij een enthousiaste professional met een passie voor kwaliteitsmanagement? Heb je ervaring in de voedingsindustrie en ben je klaar voor een nieuwe uitdaging? Dan zijn wij op zoek naar jou voor de functie van:QA CoördinatorWat ga je doen?Als QA Coördinator ben je verantwoordelijk voor het kwaliteitsmanagement voor onze...

  • QA/QC Coördinator

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Cosun Voltijd

    FunctieomschrijvingBen jij een enthousiaste professional met een passie voor kwaliteitsmanagement in de voedingsindustrie? Sta je open voor een nieuwe uitdaging? Dan is deze vacature interessant voor jou:QA/QC CoördinatorWat houdt de functie in?Als QA/QC Coördinator ben je verantwoordelijk voor het kwaliteitsmanagement van onze productielocatie in...

  • Senior Banking Specialist

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Jobs for Humanity Voltijd

    Job DescriptionPosition: Senior Banking SpecialistAre you ready to take on the role of Senior Banking Specialist in our dynamic and innovative team? As a Senior Banking Specialist, your main focus will be managing collections and payables within a specific geographic area. You will collaborate with internal and external stakeholders, develop new solutions,...

  • QA Coordinator Quality Systems

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Cosun Voltijd

    FunctieomschrijvingBen jij een gedreven professional met een ervaring in kwaliteitsmanagement? Wil je werken bij een toonaangevende suikerproducent die zich inzet voor voedselkwaliteit, diervoederveiligheid en duurzaamheid? Dan is deze functie iets voor jouQA Coördinator Quality SystemsWat ga je doen?Als QA Coördinator Quality Systems ben je...

  • Senior Risk Management Specialist

    1 maand geleden

    Amsterdam, Noord-Holland, Nederland ABN AMRO Voltijd

    This role is for a Senior Risk Management Specialist in the 1st Line of Defense, responsible for efficiently executing the Risk Management & Control Framework within Corporate Banking (CB).

  • Senior Risk Management Specialist

    3 weken geleden

    Amsterdam, Noord-Holland, Nederland ABN AMRO Voltijd

    This role is for a Senior Risk Management Specialist in the 1st Line of Defense, responsible for efficiently executing the Risk Management & Control Framework within Corporate Banking (CB).

  • QA/QC-Specialist Protein

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Cosun Voltijd

    FunctieomschrijvingBen jij in het bezit van een HBO-opleiding op het gebied van kwaliteit, voeding of microbiologie? Krijg je energie van het proactief aanpakken van kwaliteitsvraagstukken en het continu verbeteren van zowel productkwaliteit als de werkomgeving? Dan zijn wij op zoek naar jouQA/QC Specialist Protein(24 uur)Over onsJe gaat werken voor Cosun...

  • Senior Security Specialist

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Lely Holding Voltijd

    In Lely's Product Development department about 500 engineers are developing smart solutions that that help automate dairy farms. We develop a wide range of products such as milking and feeding robots, automated guided vehicles, and farm management software. With software development, both on the embedded as application side, comes cyber security. We are...

  • QA/QC Engineer Energy Island Belgian Coast

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland DEME Group Voltijd

    SummaryThe capacity of the Belgian wind farms will be greatly improved in the predicted years. A 2nd offshore wind zone is being planned in the Princess Elisabeth zone off the Belgian coast. To bring this energy ashore, an energy hub is being built in the sea, in the form of an island, more than 40 km off the Belgian coast. This island – the Princess...

  • Specialist

    5 dagen geleden

    Amsterdam, Noord-Holland, Nederland Independent Recruiters Voltijd

    For one of Europe`s largest electricity generators and producers of heat, I am looking for an experienced Senior Circularity specialist who will join the Business Area Wind's Environment & Sustainability Unit. This is a critical position that plays a crucial role in enhancing the company's approach to circularity and sustainability. Are you available...

  • Senior Specialist

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland Storio Group Voltijd

    Storio group is looking for an energetic and team-oriented Rewards Specialist to collaborate with business and HR leaders, providing expertise and guidance on Rewards policies and programs. As Total Rewards Specialist you will work on a variety of global Rewards cycle activities and Rewards-related projects as required, with an aim to elevate and expand the...

  • Senior paid search specialist

    2 maanden geleden

    Amsterdam, NH, Noord-Holland, Nederland JUSTIN recruitment Voltijd

    Het genereren van klanten en consumenten voor toonaangevende merken zoals Ziggo, Vattenfall, ING en Vodafone, dat is jouw doel als senior Paid Search Specialist.Over de functieHier ga je als paid search specialist aan de slag bij een organisatie die sinds 2017 succesvol is in het opzetten van innova

  • QA/QC Engineer Energy Island Belgian Coast

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland DEME Group Voltijd

    SummaryThe capacity of the Belgian wind farms will be greatly improved in the predicted years. A 2nd offshore wind zone is being planned in the Princess Elisabeth zone off the Belgian coast. To bring this energy ashore, an energy hub is being built in the sea, in the form of an island, more than 40 km off the Belgian coast. This island – the Princess...

  • QA/QC Engineer Energy Island Belgian Coast

    6 dagen geleden

    Amsterdam, Noord-Holland, Nederland DEME Group Voltijd

    SummaryThe capacity of the Belgian wind farms will be greatly improved in the predicted years. A 2nd offshore wind zone is being planned in the Princess Elisabeth zone off the Belgian coast. To bring this energy ashore, an energy hub is being built in the sea, in the form of an island, more than 40 km off the Belgian coast. This island – the Princess...