Job Description

Job Summary: The High-Level Quality Compliance Professional will manage and oversee pending Deviations, CAPA, and Change Control activities within the pharmaceutical manufacturing process. This role ensures that all deviations, CAPAs, and change controls are appropriately documented, analyzed, and resolved in alignment with regulatory standards and company protocols. The individual will lead and conduct thorough investigations into deviations within both the manufacturing and QC laboratory operations. They will also be responsible for the development, documentation, and management of Corrective and Preventive Actions (CAPAs) to address quality concerns and drive improvements. This position involves collaboration with cross-functional teams to identify root causes, propose solutions, implement CAPAs, monitor their effectiveness, and foster continuous improvement. Additionally, the professional will oversee the change control process, ensuring that all modifications to processes, equipment, systems, and documents are evaluated, documented, and implemented in full compliance with regulatory requirements and company guidelines.

Key Responsibilities:

• Lead and manage investigations into deviations, non-conformances, and quality incidents within the manufacturing process.
• Utilize various methodologies (e.g., Fishbone, 5 Whys, FMEA) for root cause analysis to identify underlying issues and develop effective corrective and preventive actions.
• Document investigation findings, conclusions, and CAPAs in a clear and concise manner.
• Collaborate with cross-functional teams, including Production, Quality Control, Engineering, and Technical Service, to collect relevant data and ensure timely resolution of deviations, CAPAs, and Change Controls.
• Ensure all investigations and changes comply with GMP, FDA, EMA, and other applicable regulatory requirements.
• Develop and implement CAPAs to prevent recurrence of deviations and to improve overall process quality.
• Develop and document comprehensive CAPAs based on investigation findings, root cause analysis, and regulatory obligations.
• Design and execute CAPA effectiveness checks based on scientific rationale and appropriate statistical analysis.
• Prepare and present investigation reports to senior management.
• Stay up-to-date with industry trends, regulatory changes, and best practices related to deviation management, CAPA management, change control, and quality assurance.
• Provide training and guidance to junior staff on deviation investigation techniques, CAPA writing, change management, and regulatory requirements.
• Lead and manage the change control process, including evaluating, documenting, approving, and implementing changes.
• Conduct risk assessments and impact analyses to identify potential risks and develop mitigation strategies.
• Ensure that all changes are documented in compliance with GMP, FDA, EMA, and other relevant regulatory requirements.
• Monitor the implementation of changes to ensure they are executed as planned, with no adverse impact on product quality or compliance.

Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent experience.
• A minimum of 7-10 years of experience in pharmaceutical manufacturing, with at least 5 years in a quality compliance or quality assurance role.
• In-depth knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
• Proven experience in conducting root cause analysis and implementing CAPAs.
• Extensive experience managing change control processes and conducting risk assessments.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication abilities.
• Ability to work collaboratively in a team environment, working effectively with cross-functional teams.
• Detail-oriented with a strong emphasis on quality and compliance.
• Proficiency in using quality management systems (QMS), investigation tools, and change management software.

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