Reporting to the Director, Device Quality, this is an advanced position requiring significant expertise/specialisation in area with responsibility for day to day implementation of Quality Systems and Compliance functions appropriate for our client’s combination products.
The Senior Quality Specialist will be capable of working on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to Emergent products. May assist with compliance audits as required. (passport required, 15% travel - International).
- Quality support of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements
- Executing Quality requirements in support of commercial and developmental programs
- Ensuring the realisation of industry best practices for GxP
- Serving as quality approval proxy as required.
- Responsible for Quality oversight, with management support of external manufacturing, warehousing operations, validation, verification and quality control of combination product(s) (devices).
- Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews to ensure completeness, accuracy and compliance.
- Co-ordinate with CMO Quality and Operations teams to independently resolve discrepancies while liaising with internal Quality Groups to ensure on-time disposition of Finished Product.
- Evaluation and approval of supplier and CMO change notifications. Author and coordinate applicable changes through our clients Change Management process as required.
- Author, review and approve Quality-Related Procedures as required in accordance with our client's internal procedures and GMP principles to ensure quality objectives are met.
- Active participation and support implementation of continuous improvement initiatives of the Device Quality Business Unit.
- Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor the progress of follow up actions.
- Support the stability program for combination products as required, facilitating communication and data acquisition between supply chain, contract manufacturers and stability program coordinator.
- Support the Vendor and Raw Material Qualification Program through collaboration with SQM Group To facilitate discussions between our client and CMO Quality organizations to establish responsibilities for Quality related functions.
- Provide Quality support for technology transfer across contract organisations to include; validation/verification activities and Laboratory Investigation Report review and approval for commercial and developing product pipelines.
- Support regulatory department with any regulatory filings associated with new market authorisations, annual reports and change supplements.
- Responsible for identifying defects and have the authority to report device defects at any time.
- Academic degree in Engineering or Science (preferably in an Applied Science).
- Minimum 6 years’ experience working in international device and pharmaceutical /bio pharmaceutical companies with an increased level of responsibility.
- Comprehensive knowledge of cGMP, Aseptic Manufacturing and Quality Assurance experience.
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
- Demonstrates thorough knowledge of FDA / EMEA standards and quality systems.
- Having interface with or participating in regulatory agency inspections preferred.
- Ability to deliver in a challenging environment using own initiative with little instruction on routine work, general instructions on new assignments.
- Strong mature leadership and interpersonal influencing skills showing personal/departmental accountability and responsibility.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
- Ability to operate efficiently in a complex matrix organization and international environment making sound decisions regarding compliance-related issues with minimal supervision.