Senior Quality Assurance Specialist

il y a 3 jours

Geel, Belgique Talent Source Temps plein

Description:
**Location**: Geel, Belgium**Schedule**: Full-time, permanentTalentSource Life Sciences, the CROMSOURCE flexible resourcing department, is currently working with one of our partner sponsors to hire a
- ** Senior Quality Assurance Specialist** to join their team as their permanent employee.**Main Job Tasks and Responsibilities**:
- This position will be reporting to the External Quality (EQ) Manager/Senior Manager. This position provides support to EQ Managers/Senior managers regarding Quality Assurance, Compliance, and Technical Support for external manufacturers. Provides QA support for technology transfer, PPQ, NPI introduction, and improvement of existing manufacturing processes
- Contributes to the overall development, implementation, and execution of quality systems in support of the commercial production of client products at external manufacturers. Ensures proactive and continuous compliance with applicable Health Authority regulations standards, including effective risk management.
- Conducts batch record review, and investigations perform audits, collects data, analyzes trends, and prepares reports as required. To provide support to EQ manager/senior manager on data collection during Escalation of any major/critical issues as appropriate and provide support to EQ manager/senior manager during the Management Reviews.
- Works closely with EQ Manager/Senior Managers and other internal functions (PES, TO, EHS, and Procurement, etc.), other Quality Assurance functions, and external manufacturers.
- Live Our Credo & Pursue Our Purpose:

- Pursues high standards of quality and compliance. Consistently makes Credo based decisions to take actions that prioritize customer, patient, and employee needs
- Provides support to EQ Manager/Senior Manager to ensure the success of external manufacturer qualification and monitoring, with an emphasis on continuous improvement, global alignment, risk management, and supply chain reliability. Provides balanced management of quality and compliance risks with business needs
- Provides support to EQ manager/senior manager to ensure effectuate and permanently maintain inspection readiness at the external manufacturers, including on-site representation during regulatory inspections and audits. And support EQ manager/senior manager to drive the development of corrective actions plans, as needed.
- To support EQ account owner on the quality and reliability of products produced at the external manufacturer. This role will support the EQ account owner in the continuous oversight and management of:

- Quality activities during manufacturing and quality control (including validations, issue management, troubleshooting, change management, supplier, and material management)
- Execution of monitoring and auditing activities (including the creation of quality agreements)
- Assessing quality systems and recommending improvements to enhance quality
- Reporting of quality activities, and as the needed escalation of issues to senior JSC management
- Develops self to reach their goals. Engages in open and honest conversations. Drives performance by managing energy and taking ownership for outcomes
- To support EQ manager/senior manager in the execution of quality activities such as New Product Introduction (through upscaling and launch), process improvements, and significant changes.
- To support EQ Manager/Senior Manager to ensure alignment of supplier qualification/monitoring activities with the strategic business direction.
- To support EQ Manager/Senior Manager to ensure that the quality process and systems to support Janssen product manufacturing are adhered to and maintained. Communicates expertise and guidance on relevant regulations, directives, J&J standards, and industry guidance related to quality systems design and operation.
- Support EQ Manager/Senior Manager on frequent interactions with external manufacturers, for the purpose of driving reliability, continuous improvement, Risk management, Quality strategies, and Quality System compliance.
- Communicates external manufacturer status to EQ Manager/senior manager.
- Under the supervision of EQ Manager/Senior Manager, this role might need to connect with other Quartet functions (PES, TO, Planning, etc.).
- Remaining current with local, regional and global Health Authority regulations, guidelines, and quality practices associated with cGMP and API manufacturing.

**Education and Experience**:

- Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry / Technical / Process technology / Chemical Engineering Required. Advanced degree (MS is preferred. 6-10 years of experience in the Pharmaceutical or Biotechnology cGMP environment is required.
- Experience in API, drugs or biologics quality management or
manufacturing is essential to success. Experience in External Manufacturing, Technology Transfers, Quality Event Management, and Quality System Development will be a plus
- Experience in presenting issue

  • Sr Manager, Quality

    Il y a 3 mois

    Geel, Belgique Thermo Fisher Scientific Temps plein

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Join Thermo Fisher Scientific, to discover impactful work, innovative thinking and a culture...

  • Senior Inventory Specialist

    il y a 2 jours

    Geel, Belgique Lifescan Temps plein

    **SENIOR INVENTORY SPECIALIST** **BELGIUM - WESTERLO (HYBRID WORK PATTERN) OR EU/UK REMOTE** Our vision is to create a world without limits for people with diabetes and related conditions. Join us at LifeScan, maker of the iconic OneTouch® brand diabetes products to bring to life our mission to deliver personalized health & wellness experiences that...

  • Sr Manager Eq

    Il y a 7 mois

    Geel, Belgique Johnson & Johnson Temps plein

    **"Caring for the worldone person at a time” **inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion...

  • QA Specialist

    Il y a 6 mois

    Geel, Belgique Start People Temps plein

    Binnen de QA operations afdeling zijn we opzoek naar een QA specialist voor productie plant In deze functie ben je verantwoordelijk voor quality ondersteuning van de operations activiteiten van multiproduct faciltieit. **Verantwoordelijkheden** - Opstellen en reviewen van Quality documentation in kader van project (Project notes, Quality plannen,...) -...

  • QA Specialist Operations

    Il y a 6 mois

    Geel, Belgique Jefferson Wells Temps plein

    Location: **Geel** **#22241** **QA Specialist Operations** Word jij onze nieuwe ambassador? **Jefferson Wells** Life Sciences is **gespecialiseerd** in de ondersteuning van **farma & biotech** bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in **experts** zoals jij om ons team te versterken. Laten we samen kijken naar jouw eerste...

  • Quality incident investigator

    il y a 3 semaines

    Geel, Flanders, Belgique Select Projects BVBA Temps plein

    Om ons Select Projects team bij een farmaceutisch bedrijf in Geel te versterken, zijn we op zoek naar een Quality Incident Investigator. In deze rol ben je verantwoordelijk voor het onderzoeken en beheren van kwaliteitsincidenten, zowel proces- als contaminatiegerelateerd, binnen de verschillende productie-eenheden. Je maakt deel uit van het Manufacturing...

  • Quality Assurance

    il y a 4 semaines

    Geel, Belgique Adecco Belgium Temps plein

    FunctieomschrijvingHeb jij oog voor detail en een passie voor kwaliteit? Wil je een sleutelrol spelen in het verbeteren van processen en het verhogen van klanttevredenheid? Wij zoeken een gedreven Quality Assurance (QA) Engineer die nauwkeurig werkt en proactief meedenkt om de kwaliteitsstandaarden naar een hoger niveau te tillen.Als QA Engineer ben jij...

  • Quality Assurance

    il y a 1 mois

    Geel, Belgique Adecco Temps plein

    FunctieomschrijvingHeb jij oog voor detail en een passie voor kwaliteit? Wil je een sleutelrol spelen in het verbeteren van processen en het verhogen van klanttevredenheid? Wij zoeken een gedreven Quality Assurance (QA) Engineer die nauwkeurig werkt en proactief meedenkt om de kwaliteitsstandaarden naar een hoger niveau te tillen.Als QA Engineer ben jij...

  • Quality incident investigator

    il y a 2 semaines

    Geel, Flanders, Belgique Select HR Temps plein

    Taken en verantwoordelijkhedenBij Select Projects staat de ervaring die de klant heeft met onze medewerkers centraal. Het zijn onze consultants die zorgen voor een optimale ervaring, door de hoogste kwaliteit te leveren. Jouw vakmanschap staat hierin centraal en je kan bij Select Projects verder groeien, zodat jij de beste versie van jezelf wordt én geeft....

  • Quality Incident Investigator

    il y a 3 semaines

    2440 Geel, Belgique Select HR Temps plein

    Taken en verantwoordelijkheden Bij Select Projects staat de ervaring die de klant heeft met onze medewerkers centraal. Het zijn onze consultants die zorgen voor een optimale ervaring, door de hoogste kwaliteit te leveren. Jouw vakmanschap staat hierin centraal en je kan bij Select Projects verder groeien, zodat jij de beste versie van jezelf wordt én geeft....

  • Cybersecurity Specialist

    Il y a 8 mois

    Geel, Belgique Agilitas Temps plein

    Wereldleider in staalproductie, zoekt een gedreven Cybersecurity Specialist. **Wij bieden**: - Een uitdagende functie in een afdeling van een internationale groep. - Mogelijkheden voor professionele ontwikkeling en certificeringen. - Competitief salaris en aantrekkelijke secundaire arbeidsvoorwaarden. - Een dynamische werkomgeving met een focus op teamwerk...

  • Senior Process Engineer

    il y a 4 jours

    Geel, Flanders, Belgique The Chemical Engineer Temps plein

    DescriptionJohnson & Johnson is recruiting for a Senior Process Engineer within the Manufacturing Science and Technology (MSAT) team located in Geel, Belgium.At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are...

  • Qualified Person Delegate

    Il y a 6 mois

    Geel, Belgique Pauwels Consulting Temps plein

    -geel bediende, freelancer 40 uur per week - Thomas BarbierTalent Acquisition Specialist Life Sciences 0032493096880 - **Qualified Person Delegate**: Pharma & Sciences - Quality & Compliance **Description**: - Serve as the primary contact point for QP-related issues within a designated manufacturing area. - Offer QP-related feedback to QA engineers during...

  • Elims Site Key User

    Il y a 7 mois

    Geel, Belgique Johnson & Johnson Temps plein

    **Quality Control (QC)** **eLIMS Site Key User & iLab Specialist** Within Johnson & Johnson Innovative Medicine Supply Chain, we are actively looking for a skilled and enthusiastic QC eLIMS Site Key User & iLab Specialist (M/F/X) to join our dynamic Quality team, overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product (DP)...

  • Senior Director, Small Molecules Drug Substance

    il y a 6 jours

    Geel, Belgique Johnson & Johnson Temps plein

    **We are searching for the best talent Senior Director, Small Molecules Drug Substance to be in Geel (Belgium), Beerse (Belgium), or Schaffhausen (Switzerland).** **Purpose**:Position is responsible for leading a global, mature team responsible for managing effective relationships for the manufacturing operations of contract suppliers and alliance partners...

  • Quality Incident Investigator

    il y a 1 mois

    2440 Geel, Belgique Select HR Temps plein

    Taken en verantwoordelijkheden Bij Select Projects staat de ervaring die de klant heeft met onze medewerkers centraal. Het zijn onze consultants die zorgen voor een optimale ervaring, door de hoogste kwaliteit te leveren. Jouw vakmanschap staat hierin centraal en je kan bij Select Projects verder groeien, zodat jij de beste versie van jezelf wordt én geeft....

  • Senior Process Engineer, New Product Introduction

    il y a 4 jours

    Geel, Flanders, Belgique Johnson & Johnson Temps plein

    Job Description - Senior Process Engineer, New Product Introduction (2406227828W)Johnson & Johnson is recruiting for a Senior Process Engineer within the Manufacturing Science and Technology (MSAT) team located in Geel, Belgium.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where...

  • Msat Development Specialist

    il y a 2 heures

    Geel, Belgique Source Group International Temps plein

    We are currently seeking a **MSAT Development Specialist** to work for a leading pharmaceuticals company in Geel, Belgium. This is a contract role expected to last a minimum of 6 months with potential to extend another 3-6 months based on project needs. The project site revolves facilitates the production of therapeutic proteins which takes place via cell...

  • Safety & Health Specialist

    Il y a 7 mois

    Geel, Belgique Kuehne+Nagel Temps plein

    We are looking for a Safety & Health Specialist to join our team in Tessenderlo. ** Your Role**: The Safety & Health Specialist oversees and actively supports safety, health, and environmental programs, training, inspections, and related documentation and recordkeeping. You are part of the SHE team that supports safety, health, and environmental management...

  • Procurement/sourcing Specialist Ii

    Il y a 7 mois

    Geel, Belgique Thermo Fisher Scientific Temps plein

    Business Job Title: Procurement Specialist Job Profile Title: Procurement Specialist II Direct Report To: Procurement Supervisor Group/ Division: LSLPG / Laboratory Chemicals Division (LCD) Career Band: Band 5 Career Track: Professional Position Location: EMEA: Geel, Belgium. Loughborough, UK. Heysham, UK. Number of Direct Reports: 0 When you’re...