15386351 – QC Training and Compliance Specialist Contractor

Purpose

This is a 10 month contract

This position is responsible for actively identifying opportunities for process and compliance improvement within the QC lab and translating these into practice. In addition, this role is responsible for ensuring QC methods and processes are compliant to compendial and regulatory requirements. This role will also be responsible for oversight of the QC Quality System, ensuring adherence to Quality System processes and procedures and training staff on Quality Systems. In this role, you should have excellent relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Responsibilities

• Oversight of the training program for the QC department including the delivery of training on technical topics to the QC team.
• Design and maintenance of a robust onboarding and training program for new starts to the QC team.
• Develop and deliver technical training as required and support development of SME’s within the Microbiology team..
• Identify, lead and implement continuous improvement initiatives which ensure maintenance of cGLP, inspection readiness, data integrity and eliminate/reduce risk.
• Lead the introduction of new methods/techniques/technologies into the QC Microbiology laboratory and ensure compliance of existing methods/processes to compendial and regulatory requirements.
• Manage the continuous improvement program for QC including planning and facilitating workshops and supporting the translation of the output to procedural/process updates.
• Documentation flow and paperwork practices – Improving Right First Time and reducing GDP errors within QC and implementing processes to track and trend performance against targets.
• Support investigation of major laboratory investigations, identifying and implementing robust CAPA’s to prevent recurrence.
• Develop simplified and effective scheduling for routine/non routine activities to maximise available resources.
• Generation of QC metrics and presentation of metrics to QC management on a monthly basis.
• Actively participate in and support inspection readiness for the QC Department acting as SME as required.
• Present and report on project progress and continuous improvement to QC management on a monthly basis.
• Maintain regular and proactive communication with all stakeholders.

Minimum Qualifications and Experience

• BSc./MSc. Degree in science/pharmaceutical related subject (preferably Microbiology).
• At least 5 years’ working in a GMP Quality Control Laboratory.
• Knowledge and understanding of GMP/GDP standards.
• Strong problem solving and leadership experience.
• Experience in workshop facilitation.
• Experienced in leading and executing continuous improvement initiatives.
• Experience of SOP authoring and document management processes.
• Highly Computer literate, with MS Office (Word, Excel).
• Experience of provision training to others.
• Good working knowledge of QC Microbiology and lab practices and troubleshooting.
• Knowledge and experience with Chemistry instrumentation and methods is beneficial but not essential.
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Excellent communication & presentation skills are essential.
• Excellent time management organizational skills along with a proven ability to multi-task.