Reports to: Senior Quality Director
MAIN PURPOSE OF JOB
The Senior QA Officer is responsible for the maintenance of the Quality Management System (QMS) and performance of associated Quality Assurance activities at Evox. To assure appropriate Quality Systems are in place at approved vendors and suppliers providing business critical, Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP) services to Evox. Establishing the processes and mechanisms to ensure that all relevant quality and regulatory requirements are met for quality control testing and contract manufacturing. Ensures site compliance with Quality regulations issued by MHRA, FDA and other applicable regulatory bodies where Evox’s products are being developed.
- Lead the development and maintenance of the Evox Quality Management System (QMS) in accordance with applicable standards (MHRA, FDA, etc).
- Ownership of core QMS processes and drive a Continuous Improvement philosophy
- Support the development of a Supplier Quality program and set-up of GLP/GCP facing processes
- Interface and support internal teams including Product Development, Research and Clinical facing teams in support of securing an IND or MIA licenses as appropriate.
- Work with external vendors such as Contract Manufacturing Organizations, and other service providers to ensure compliance with Evox requirements and quality standards.
- Support the development of a Data Integrity framework across Evox
- Ensure QA standards are maintained in control of documentation, staff training, facilities and equipment
- Review batch manufacturing and testing records and all associated data in preparation for both primary / secondary packaged material / material for clinical trial supplies
- Manage programme of internal and external audits / lead internal audits
- Leadership of QA investigations
- QA review and approve Evox technical documentation from Research, Development and Clinical functions. This will include: SOPs, Certificate of Analysis, reports & protocols, laboratory notebooks, in-house batch records, facility & equipment records.
- Provide QA support for the development of new processes or testing methods developed at Evox.
- Assist (lead where necessary) external audits of contractors
- Generate metrics to support the monthly Quality Council process
- Staff training in QA procedures
- Interfaces with Evox QP and other QA consultants
EXPERIENCE AND KNOWLEDGE
- Degree (BSc) in an appropriate science subject
Experience and skill requirements:
- Proven experience within the pharmaceutical/biotech industry in a QA function. The holder is likely to have other relevant experience within the industry, such as QC testing or GMP production / working in a GCP/ GLP environment
- Supplier Quality Management or audit experience would be advantageous
- Experience of working in a company which is
- Knowledge of Data Integrity requirements and experience of supporting investigatrions - ability to define problems and prioritise issues
- Ability to plan and organise workload including evaluation and prioritisation of current tasks and forward planning for future events
- Demonstrate ability to make decisions, take responsibility and exercise judgement
- Use initiative to resolve problems, anticipating and pre-empting situations and handling pressure
- Strong team player to work towards team goals and effectiveness
- Good verbal and written communication skills
- Strong attention to detail
- Show enthusiasm, energy and commitment to role
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.
Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.
Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.
Candid and Constructive – We communicate with honesty and transparency throughout the team. We value giving and receiving constructive feedback to each other and our partners.