Job Information
Cambrex High Point Quality & Operations Analyst in UNAVAILABLE, Belgium
Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
The Quality and Operations Analyst is responsible for the execution of all Q1 Scientific QMS and Operations activities.
Responsibilities
Reporting to : The Quality Lead.
Main responsibility:
The Quality and Operations Analyst is responsible for verifying that quality is being maintained throughout the stability storage and sample management process. The person is also responsible to receive the samples and to participate the stability storage management, together with the management of the facility and its equipment.
Specific responsibilities include but are not limited to:
QMS:
Provision of assistance and advice to the Company on all QMS activities.
Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP and GDP standards.
Continually monitors the QMS system suggesting improvements and CAPA measures.
Provision of assistance for administration of quality manuals, continuous improvement initiatives & interaction with management personnel on quality initiatives.
Performing investigation for all CAPA following planned and unplanned deviations, quality events.
Audits:
Ensure compliance to GMP and GDP certification by provision of assistance in reporting internal reviews.
Participate to all internal, regulatory, supplier and customer audits.
Operational Activities:
Administration of quality and operations documents, continuous improvement initiatives and interaction with management personnel on quality and operations topics to include but not limited to:
Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.).
Maintenance of indexes (electronic and hard copy)
Review of completed documents for compliance to specification and to ensure all entries are complete.
Proposing/reviewing document changes as appropriate.
Checking off second signature for Operations as appropriate.
Performing daily checks on stability cabinets/room conditions as appropriate
Providing support as required for checking of samples on receipt at Q1 Scientific/on return to Client as appropriate.
Providing general admin support as required.
Facilities Management :
Provision of assistance for the cleanliness of the facility and compliance with equipment and maintenance schedules, in line with the quality management system.
Be available in case of urgent interventions at the facility out of normal working hours (repairs, breakdowns, …)
Assist in the development, optimisation and validation of new equipment.
Contribute to extension projects of the facility
Order consumables and maintain sufficient quantities of office supplies and sundries.
General Office Administration :
Answering telephone calls and emails and dealing with problems in a timely manner.
Maintain administrative records, including invoices, delivery notes and contractor reports.
Liaise with external consultants and contractors.
Backup role :
Act as backup of the Quality Lead, the Operations Lead and the Stability & Operations Analyst.
This is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organisation and the overall business objectives of the organisation.
Education, Experience & Licensing Requirements
Primary degree in science
Experience in working in a regulated environment
5-8 years’ experience in QA
Hours of Work
Monday – Friday (flexible hours allowed between 07:00-20:00)
There is some flexibility around these hours once all operations and opening hours are covered
Out of normal working hours are possible (weekend, evening, night, …)
Place of Work
Company’s offices at Villers-le-Bouillet, 119, rue de Waremme
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.