Continuous Improvement & Compliance Senior Specialist

Overview:

The Continuous Improvement and Compliance Senior Specialist is responsible for driving process improvements and ensuring regulatory compliance within the pharmaceutical industry. This role involves analyzing existing processes, identifying areas for improvement, and implementing best practices to enhance operational efficiency while maintaining adherence to industry regulations.

Responsibilities:

The Continuous Improvement and Compliance Senior Specialist is responsible for the following tasks and responsibilities:

• Process Improvement for Bulk, Packaging and Warehouse:
• Collaborate with cross-functional teams to identify opportunities for optimization,
• Develop and implement strategies for continuous improvement, using methodologies such as Lean or Six Sigma.
• Author and/or review production documents, including working practices, protocols, master batch record and follow up approval flow within electronic documentations system.
• Project Management:
• Lead and participate in cross-functional projects aimed at enhancing operational performance and compliance.
• Initiate, own, and follow up change controls related to manufacturing or warehousing. Manage stakeholders involved.
• Regulatory Compliance
• Ensure that all processes and practices comply with relevant pharmaceutical regulations and standards (e.g., FDA, EMA).
• Train the operational team to the procedures/protocols as required
• Initiate deviations and participate to, or lead on the floor complex investigations. Partner with QA, Warehouse, Packaging and Bulk Operations to ensure assessments and investigations are exhaustive.
• Follow up and implement assigned CAPA’s.

Qualifications:

• BS/MS in Engineering/Technical discipline or equivalent experience
• 5 years’ experience in pharmaceutical validation, production, packaging or related field

Knowledge / Skills / Abilities:

• Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
• Knowledge of pharmaceutical facilities, manufacturing systems and processes.
• Well-developed ability to constructively work across functional areas and levels to achieve results,
• Strong verbal and written communication skills,
• Strong analytical, problem solving, influential and deductive skills,
• Capability to work with short deadlines and simultaneous activities,
• Excellent organizational and project management skills,
• Fluent in English and in French.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.