C&Q Sme, Panda International | VINDAZO in België

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Solliciteren

Plaats

Brecht
België
België

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2026-03-04

Online to:

2026-05-04
EUR 15.00 HOUR

C&Q Sme

Panda International
België
7 uren geleden

C&Q SME (Commissioning & Qualification Subject Matter Expert) Objectives and Responsibilities The function holder: Supports the C&Q group in providing documented evidence that all equipment and utilities used within the organization are qualified and remain in a state of control to ensure processes and products comply with regulatory and business specifications. Is responsible for coordinating assigned qualification activities. Is responsible for the technical content of assigned equipment qualification files. Acts as a Technical Owner within the organization. Main Tasks / Additional Tasks / Authority Technical and Function-Specific Tasks and Responsibilities Performs detailed assessments for assigned projects, changes, modifications, best practices, corrections, remediations, breakdowns, non-compliance issues, and investigations. Forwards requests to the C&Q Lead when appropriate. Participates in core team and planning meetings for assigned projects. Keeps work overview tools (e.G., Kanban boards) up to date. Requests support or information from the C&Q Lead when needed and escalates when required. Documents assessments and completed tasks in the applicable system(s). Communicates with involved departments regarding test planning, materials, and resources for assigned projects. Shares relevant project information with qualification engineers. Provides updates and support to qualification engineers as needed. Supports and, when necessary, guides qualification engineers in evaluating project issues and changes and assessing impact on qualification activities (e.G., protocol deviations, scope changes). Collaborates with qualification engineers to ensure qualification activities are performed qualitatively and within reasonable timelines. Reviews and approves qualification documents (e.G., URS, SRS, SIA, CARA, DQ, QP, IQ, OQ, discrepancies, PQ, QSO) in the electronic validation system. Collaborates with QA to obtain approval of qualification files. Acts as qualification engineer/technical writer when required. Reviews executed qualification tests documented by qualification engineers or other testers. Initiates and follows up on non-conformances and corrective actions in the applicable system(s) when required. Contributes to internal C&Q improvement initiatives. Assists in preparation for and support during internal and external inspections. Supports the maintenance of Validation Master Plans, including system inventories and qualification status. Assists in providing introductory qualification training. Acts as backup for other C&Q SMEs when required. Ensures proper handover of responsibilities before extended absences. Quality and Compliance Responsibilities Operates in compliance with GMP requirements. Maintains up-to-date knowledge of international regulations, guidelines, and industry practices related to system and process equipment qualification. Identifies procedural or documentation gaps and informs the C&Q Lead. Strives for high-quality qualification documentation. Identifies improvement opportunities and reports them appropriately. Completes all mandatory training within required timelines. Staff Responsibilities Coaches qualification engineers. Provides feedback on quality of work delivered. Supports onboarding and training of new team members when requested. Qualifications & Experience Minimum 5 years of relevant pharmaceutical experience in a GMP-regulated environment. Technical knowledge of aseptic/sterile equipment and processes required. Technical or scientific educational background preferred. Local language proficiency is a plus. Experience with electronic validation systems is a plus.

Solliciteren

C&Q Sme

Plaats

Contract

Datum gepubliceerd

Online to:

C&Q Sme

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