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.