C&Q SME

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.