Principal QA Specialist

• JOB DESCRIPTION:Being accountable and act as a Subject Matter Expert for Quality at the site level with the primary focus on:
• SQC preparation and publishment – being accountable for the preparation and coordination of the monthly SQC slides and summaries and the required data. After the meeting, finalisation of the meeting minutes and publication in the local DMS system.
• Deviation process including Track & Trend, quarterly reports, monthly emails – represent the site during the global meetings, coordinating the communication and any questions raised. Be the main point of contact for any questions raised, audit observations , CAPAs associated with this topic. Be responsible for providing strategic expertise in this topic. Be responsible for resolving escalated PQS internal issues.
• Calculate / review deviations Event Category limits
• QRM process – being accountable for ensuring the process is aligned with the Global standards. Act as a SME for QRM related questions, audit observations, CAPAs and others. Be responsible for providing strategic expertise in this topic. Be responsible for resolving escalated PQS internal issues.
• PQS statistic tools used for preparation and extraction of the data, statistical analysis to support the compliance of the business.
• Monitor and interpret quality metrics and ongoing quality trends for risks and deviations to provide information to the Site.
• Ensure actions are taken in timely manner to address trends and when issues are highlighted.
• Ensures execution of work of self and others is performed in accordance with established procedures.
• Executes the site Quality plan and deliverables, as assigned.
• Routinely reports on quality and compliance issues.

Provides continued inspection readiness at site including ongoing remediations and in line with regulatory standards. Utilise knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective , efficient, simple and compliant.

– Identifies and addresses gaps. Ensures thoughtful implementation of solutions.

– Champions innovation and LBMS implementation to ensure sustainably.

– Demonstrates timely and accurate decision making, ensuring delegation or escalation where appropriate

– Identify opportunities for GMP compliance training and awareness campaigns – design , develop and deliver.

– Takes personal responsibility for promoting change.

– Understands how to effectively engage others in the change processes.

– Problem-solves with a strong sense of purpose and urgency and makes recommendations to Management regarding serious compliance or quality issues.

– Perform all business-related activities that may be reasonably requested and as instructed by the respective line manager and /or Senior Management Team.

DEGREE REQUIRED: BSc in Science or QA discipline.

WORK EXPERIENCE: • Has the personal determination to make performance happen with people not in reporting lines.

• Excellent decision making skills.

• Ability to meet strict deadlines.

• Excellent organisational and planning skills.

• Ability to streamline/ lean processes. Be open-minded with the enthusiasm and motivation to learn, improve and innovate.

• Demonstrates an ability to see the big picture.

• Excellent communication skills (verbal and written).

• Believes diversity creates strength within the team.

• Embraces and creates collaborative relationships.

• Has the clarity of thought to deliver clear unambiguous communication.

• Excellent project management skills. Be able lead by example.

• Demonstrates an ability to champion quality concepts and influence others.