- You will be responsible for qualification activities of Production and/or Development equipment (including utilities) as well as GMP laboratory equipment, whether computerized or not, in compliance with cGMP, internal and external guidelines, and HSE rules, in accordance with the Validation Master Plan (VMP) of the Braine-l'Alleud Site.
- You will ensure the validation of manufacturing processes in compliance with cGMP, HSE rules, and in accordance with the Validation Master Plan (VMP) of the Site.
- You will ensure the validation of cleaning processes for equipment used in the manufacturing processes, following cGMP, HSE rules, and in accordance with the Validation Master Plan (VMP) of the Site.
- You will deploy operational qualification and validation activities at the Business Unit (B.U) level. You will participate in routine and project activities as a Subject Matter Expert (SME) in Qualification/Validation. You will ensure the qualified status of production equipment according to the initial qualification and periodic review schedule.
- You will ensure the permanent auditability (Permanent Inspection readiness) of qualification records for systems and production equipment.
- You will take charge of qualification projects for systems and production equipment and/or laboratory equipment assigned to you, following defined schedules.
- You will participate in budgeting for initial qualification/validation of equipment. You will define and propose the qualification/validation strategy for the systems and production equipment you are responsible for (routine and/or project activities).
- You will participate in conducting quality risk assessments.
- You will define the validation/cleaning validation strategy in agreement with the project team.
- You will draft/approve the validation plan and associated qualification documents (qualification protocol/report, validation protocol/report, etc.).
- You will coordinate/execute/verify qualification/validation tests.
- You will inform your hierarchy and stakeholders of any deviations and suggest necessary corrective actions.
- You will make necessary decisions in case of deviations impacting the qualification strategy.
- You will ensure data is processed and statistically interpreted.
- Depending on workload and organization, you may perform other activities under the supervision of your manager or a department manager.
- You will conduct Periodic Reviews of systems and equipment assigned to you. You will coordinate Periodic Reviews under your responsibility.
- You will ensure compliance with the Periodic Review schedule (Compliance Requirement).
- You will contribute to the establishment of an effective and standardized approach to qualifying systems and production equipment.
- You will stay updated on technological and regulatory developments to sustain the expertise of the Braine Site Process Validation department.
- You will develop partnerships with internal clients, internal support services (IT, Metrology, Periodic Controls), and external suppliers.
- You will collaborate with the Quality Assurance Service to ensure compliance with current regulations, guidelines, standards, and internal procedures (SOPs).
- You will participate in internal audits, external audits, and regulatory inspections (national and international authorities, FDA, EMEA, etc.).
- You will ensure compliance with current legislation and HSE rules. You will contribute to maintaining a positive work environment and team spirit.
- Through this position, you will embody UCB's principles and values in your daily work and contribute to respecting and upholding safety rules and current legislation.
- You have a master's degree or equivalent through experience.
- You have a minimum of 3 years of experience in equipment qualification, process validation, and/or cleaning process validation.
- Knowledge of pharmaceutical industrial processes (chemical synthesis, formulation, packaging).
- Knowledge of laboratory equipment qualification techniques.
- Knowledge of Qualification/Validation techniques. Knowledge of cleaning techniques.
- Knowledge/experience of the Verification Approach (ASTM E2500).
- Knowledge/experience in utility and HVAC qualification is a plus. /
- Knowledge of IT/Computerized System Validation techniques.
- Knowledge of cGMP, CFR, ICH, and HSE standards.
- Ability to take responsibility and make decisions. Language skills: French, English.
- Knowledge of other languages is a plus.
- Ability to manage interactions with external suppliers to UCB.
- Ability to be innovative and take initiatives.
- Ability to integrate into a team, an organization, and interact with numerous stakeholders in the context of activities/projects.
- Excellent analytical and synthesis skills, especially in problem-solving.
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Equipment Laboratory Valid. Associat - Braine-l'Alleud, België - UCB
Beschrijving
Make your mark for patients
We are looking for an innovative, entrepreneurial, and analytically minded Qualification/Validation Associate to join our Site Process Validation team at our UCB Braine office in Braine-l'Alleud, Belgium.
About the role:
Who you'll work with:
The role is part of a dynamic team that values collaboration, positivity, and friendliness.
This role covers all aspects of qualification and/or validation activities for systems and production equipment, from active pharmaceutical ingredient synthesis (chemical and/or biological) to packaging, including utilities and stores.
What you'll do:
Interested? For this role, we are looking for the following qualifications, experience, and skills:
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
