My client is a high-performing, team-based pharmaceutical organisation focused on developing therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic disease, where colleagues are flexible, multi-skilled and empowered to make decisions.
This position is responsible for delivering the validation programs on projects at the organisation's Global External Operations. This position is responsible for the execution, review and approval of validation activities in a GMP regulated environment, focused on implementation of new manufacturing processes, technical transfers, packaging and shipping validation.
- Provide oversight for validation activities related to products, process, packaging and shipping validation activities through close collaboration internally and externally with CMO's, ensuring compliance with specifications, regulatory guidelines and right first-time delivery.
- Developing validation plans and rationale for process, packaging and shipping validation activities.
- Responsible for shipping validation of products through the various GMP manufacturing nodes across sites.
- Execute (protocol generation, execution, and final package preparation and reports) validation activities related to shipping validation.
- Lead and represent MSAT Validation in multi-departmental meetings & project teams.
- Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Logistics, Packaging Development, Quality Control, Quality Assurance, Regulatory Affairs and others.
- Identifies and implements improvements to the MSAT Validation systems.
- Assist with preparation of regulatory filings, responding to questions from regulatory agencies, and with presentation of materials during regulatory inspections /partner audits.
- Participation in the change control program for modifications to qualified processes.
- Establish Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the organisation, validation techniques/approaches and systems utilized.
- Other duties as assigned.
Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- 5+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in process, packaging and shipping validation.
- Organizational and management skills to coordinate multi-discipline project groups.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process and cleaning validation expectations.
- Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
This position will require interaction with multiple levels (in Manufacturing, Process Sciences, Process Development, Logistics, Packaging Development, Quality Control, Quality Assurance, Regulatory Affairs and others.
There are currently no direct reports to this position. This position may have consultants/contractors reporting to it on a project basis.
~~Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Apply now or contact Anita Osibuamhe at 016321870 or send an updated CV for a confidential conversation today.