Complaints Specialist Our partner is looking for a Complaints Specialist to join its teams. This international company is well known for its pharmaceutical products. Your responsibilities?
Carrying out, documenting and reviewing the complaints, including evaluating the possible impact on the patients and providing an answer to the hospital / care provider / patient.
Guaranteeing the correct balance statement by investigation level per type of complaint. It is important to be able to differentiate between product-related complaints that are specific to the product and process-related complaints, which can be caused during our production process and thereby rationalize the appropriate level of research.
Monitoring and follow-up of the trending of complaints on a daily, monthly, quarterly and annual basis. By using the necessary statistical tools and mapping the complaint ratio. Based on this, an evaluation is made of the need to start up additional actions with the intention of reducing the complaint ratio.
In the case of process-related complaints, act as a facilitator between the involved departments, work with experts from production, product support and other departments and lead the cross-departmental meetings on this and guarantee that the investigation is conclusive.
Ensure notification to higher management regarding significant quality issues and complaints and corrective & preventive actions taken.
Ensure complaint management in a timely manner and in accordance with PQS, GMP and relevant medical device and combination products requirements.
Respect the PGS vision, mission, values and leadership behaviors in order to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time.
Let's talk about you!
Strong written communication skills: for technical reports
Analytical skills (data analysis)
Persuasiveness: you can bring different parties together to arrive at the best possible solution
Good time management and prioritizations skills
Team player
Proven problem solving abilities
Talen (Languages):fluent in Dutch and English
Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Our partner is looking for a Sr Specialist Change Control Management to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Execution of PES supplier change control processes in conformance to current standards and procedures, using applicable system application tools.
Ensure integrity, consistency and compliance of processes for JSC globally.
Assure successful implementation of changes and actions by following up and synchronizing activities for all participants, communicating status for implementations to key stakeholders
Provide product and Supply Chain knowledge to ensure proper implementation and compliance
Partner with other areas of Supply Chain and actively develop and manage relationships with process users, business owners, affiliates and external organizations.
Let’s talk about you !
Bsc in Physical or Life Science; Supply Chain and/or Chemical Engineering
3-5 years of related experience, including significant experience in pharmaceutical or other related highly regulated industry
Min. 3 years’ experience in leading virtual teams
Strong Project Management Skills
Demonstrated experience to lead complex change implementations confidently.
Demonstrated understanding of manufacturing processes and associated GMP compliance requirements. Able to apply this knowledge to lead and develop change control process strategies for global needs
Demonstrated understanding of global Regulatory Affairs legislation and Regulatory Compliance requirements. Able to apply this knowledge to evaluate changes and assess potential risk introduced to the business as result of changes
Ability to engage and align with other diverse and dispersed organizations and functions.
Ability to negotiate, influence and lead without direct line authority.
Ability to engage others and lead an organization through continuous improvement and change.
Excellent communication skills
Have attention to detail and are organized; follow and establish processes
Proficient in written and spoken English and Dutch
Ability to work independently
Ability to understand the content of changes
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
QA Document Support 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 challenge bij ons!
Takkenpakket?
Beheer van:
Documentatie
Deviatie & CAPA
Change Control
Health, Safety & Environment
Quality Third Party
Audit management
Complaint management
Risk management.
In het kader van dit project, hebben wij een opdracht vacant voor documentatie relateerde taken binnen een GMP kader. De opdracht omhelsd oa:
voorbereiden en updaten van documenten ism de document owner
processen van documenten in het documentatiesysteem
Account management
voorbereiden van master data, ism de data owner
Profielverwachtingen?
Je hebt 1-2 jaar ervaring in GMP omgeving/gecontroleerde documentenbeheer
Je bent vlot in het NL/ENG
Je bent Nauwkeurig
Je bent Doelgericht
Je bent zelfstarter/initiatiefnemer
Je bent communicatief vaardig
Je bent een teamplayer
Je hebt ervaring in digitale tools
Wat kan Jefferson Wells voor jou betekenen? Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen. Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!
Dissolution Sciences is part of the Global Analytical Development organization within the Chemical and Pharmaceutical Development & Supply (CPDS) department. We develop dissolution and in vitro release methods for immediate, modified, and targeted release formulations for oral, parenteral, and other administration routes. We investigate, characterize, and predict release rates in standard and biorelevant dissolution media. We validate and transfer methods, and we investigate deviating release rates to improve our methods and drug products.
The position will be performed out of the Beerse Campus in Belgium.
Job Title: Scientist
Job Description You will apply the latest scientific thinking in dissolution testing to help bring new drug products to patients.
The successful candidate • Will craft, plan, and perform dissolution experiments • Will improve the mechanistic understanding of dissolution rates by applying data analysis and modeling • Will represent Dissolution Sciences in cross-functional teams consisting of pharmaceutical, clinical, and regulatory scientists to support drug product development. • Will support the biopharmaceutical assessment strategy and deliver clinically relevant dissolution methods and specifications.
Qualifications Education & Experience • PhD or MSc in Pharmaceutical Sciences, Biopharmaceutical Sciences, or related field. • Knowledge of local delivery formulations and long-acting formulations is a plus
Competencies & Knowledge • Performing research and development in a GMP environment • Fast learner with scientific curiosity and creativity • Proficient in written and oral English • Ability to present in a clear and concise way • Knowledge of Dutch or willing to learn the basics.
Our partner is looking for a QA Engineer Alliance Products to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Key Responsibilities:
Ensure GMP compliance products manufactured and/or tested at a contract facility.
Ensure all aspects of product manufacturing and/or testing are reviewed versus established
Quality standards and the applicable marketing authorizations.
Manage quality systems, e.g. change control, deviations, and product investigations.
Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished products meet Sanofi and GMP requirements.
Contribute to the completion of milestones associated with specific projects.
Core Responsibilities:
Review batch abstracts to release products in accordance with approved specifications and procedures.
Monitor contractor compliance via GxP documentation review and on-site visits/audits.
Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
Interact with multi-functional internal and external project teams to ensure compliance.
Respond to technical and quality issues and handle schedule and/or process-related conflicts.
Demonstrate understanding of applicable regulations related to the manufacture of medicinal products (biologics).
Manage notification flows in quality systems between internal and external partners
Monitor contractor performance to establish Key Performance Indicators (KPIs) and report adverse trends.
Provide guidance to less experienced staff, as applicable.
Your profile?
Bachelor’s or Master's degree and 3-5 years of experience in a cGxP or other regulated environment, whereof 3 years in a quality role. Experience in a regulatory affairs (RA) role is a plus
Excellent communication and organizational skills.
Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).
Being fluent in English is a requirement (writing & speaking), Dutch is a plus
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
