Internal Operations Quality Partner
As a member of the Clinical Supply Quality team, the Internal Operations Quality is responsible for, but not limited to the QA review of IMP batch records, ensuring the prompt resolution of all batch manufacturing issues and ensuring close out of development related CAPAs. This role provides direct partner driven, pragmatic and proactive support for development manufacturing.
The Internal Operations Quality is responsible for ensuring that appropriate quality systems are in place for the production, the release and the distribution of IMP for Clinical trials as required by the development team.
In addition, the Internal Operations Quality is responsible for QA release support during regulatory inspections, active participation in the selection, evaluation, approval, and maintenance of vendors and also and quality improvement initiatives.
The Responsibilities
- Provide timely and efficient GMP/GDP IMP Release function to all relevant project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…).
- Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health, and safety, etc.
- Support the systems and processes in place for the appropriate documentation of development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
- Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
- Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
- Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
- Provide support in the evaluation of Temperature excursions for IMP.
- Management of Quality Complaints of IMP.
- Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
- Ensure adequate QA support for the qualification, validation, and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas or laboratories, as well as related cleaning validations.
- Contribute the preparation of audits (internal/external, regulatory inspections)
- Implement and maintain adequate Quality & Compliance Indicators and communicate results to
- appropriate levels of the organization
- Ensure and maintain the adequate accreditation for the packaging facilities (CPLO)
- Lead internal audits / Self-Inspections Process.
- Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant). Support the Head of Clinical
- Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities.
- Actively participate in identifying, developing, and implementing local quality and operational excellence improvements in response to business requirements, technical changes, and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.
- Ensure Clinical supply Quality processes directly support Technical Operations and development partner goals and objectives.
- Review and QA approval of deviations, change controls and complaints.
Knowledge and skills Requirements
- Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese).
- QA/compliance experience in pharmaceutical regulated environment.
- Function effectively with minimal supervision.
- Good teamwork and project management skills. Must have strong, organization and analytical skills.
- Must be fluent in English, other languages are a bonus.
- Facilitator, influencer, and planner.
- Fact based decision maker: understand complex issues and can contribute to informed.
- decision making when working on “grey” issues.
- Able to make/influence quality/compliance decisions in a CMC development environment.
- Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing, and solving problems).
- Experience of participation in failure investigations.
- Familiarity with risk analysis techniques.
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
