Position Overview:
We are seeking a highly experienced C&Q Component Preparation & Formulation Lead to manage and oversee commissioning and qualification activities for the Component Preparation & Formulation scope of a new drug product manufacturing facility. This role is crucial in ensuring that systems, equipment, and facilities comply with cGMP standards and regulatory requirements, and are fit for their intended use.
Key Responsibilities:
- Lead the planning, execution, and documentation of C&Q activities for the designated Component Preparation & Formulation, including equipment, utilities, facilities, and processes.
- Develop and maintain area-specific C&Q plans, test strategies, and supporting documentation.
- Collaborate with cross-functional teams (Engineering, Operations, Quality, Contractors) to ensure timely and compliant execution of C&Q deliverables.
- Provide subject matter expertise on pharmaceutical standards (e.g., GAMP, ISPE, ICH) and regulatory expectations (e.g., FDA, EMA).
- Review, approve, and ensure completeness of C&Q documentation, including protocols, risk assessments, and summary reports.
- Track and resolve discrepancies, deviations, and change controls related to C&Q activities.
- Drive continuous improvement initiatives to enhance C&Q processes and reduce project risk.
Qualifications:
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- 5-10+ years of experience in Commissioning & Qualification within a GMP-regulated environment, preferably in the pharmaceutical or biopharmaceutical sector.
- Proven leadership experience managing C&Q teams or specific project areas.
- Strong technical knowledge of commissioning, qualification, and validation practices.
- Deep understanding of regulatory guidelines and industry best practices (FDA, EMA, ICH, ISPE, GAMP).
- Experience with digital validation tools (e.g., Kneat, EDMS).
- Excellent communication, leadership, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple priorities in a fast-paced, dynamic environment.
- Key Experience: Candidates should have a practical mindset and be self-starters. Essential traits include strong communication abilities, experience with large-scale project delivery, and proficiency in digital documentation tools.
- Problem-Solving Skills: Ability to engage with vendors and effectively communicate resolutions to issues.
- Team Collaboration: Excellent communication skills are crucial for managing cross-functional teams during C&Q activities.
- Continuous Improvement: Self-starting individuals who can adhere to schedules and drive improvements are ideal.
- Expertise Needed: Familiarity with single-use technologies like SUMs, Partwashers, and Autoclaves is essential.
- Quality Compliance: Candidates should execute tasks with a "right-first-time" approach.
