QA Officer

Major Duties and Responsibilities

• Ability to write and Review Quality documents, protocols and reports in accordance with procedural requirements and current regulatory standards.

• Lead and author risk assessment, FMEA and other root cause analysis techniques to provide appropriate information on product and processes.

• Leads the execution of Sitewide QA activities and ensures all deliverables are met within agreed project/ procedural timescales.

• Works in collaboration with other departments.

• To communicate instantly any problems/queries to QA Supervisors/ QA Manager.

• Identifies quality events and potential root cause determination and raises appropriate corrective and preventative actions.

• Supports/ own quality events investigations/ root cause analysis cross functionally.

• Revises and review standard operating procedures and WRKs in line with company policies and procedures.

• Collate and supply quality data necessary for regulatory submissions

• Conducts risk/ gap assessments of the QA/ job related processes to identify opportunities for improvement.

• performed in line with procedural and regulatory requirements.

• Raise and progress Change Controls as required.

• Complete CAPA and assigned actions as required.

• Ensures delivery of key Quality Organisation Metrics in relation to QA activities.

• Completes statistical analysis as per the in house procedures and investigations.

• Ensues safety standards are met and maintained.

• Recommends, develops and implements systems to improve QA activities

• Foster trusting and collaborative relationships with internal customers to gain perspective and effectiveness when dealing with operational issues.

• Where applicable, direct team members towards achieving daily and long-term business goals. Effectively monitor and manage progress and performance and provide timely feedback to the relevant teams and team members.

• Supports with Process improvement projects and Tech Transfer of new products ensuring the process is performed in line with procedural and regulatory requirements.

• Demonstrates competencies in all QA activities

• Ability to coach and mentor colleagues in area of expertise.

• Lead Internal Auditor.

• Fronter in Client/ Regulatory Audits.

• Supports internal and external audits as required – including Back room/ front room support.

• Drive compliance to MHRA, FDA, Regulatory and Company requirements / standards.

• Provide relevant solutions and proposals to facilitate any decision-making processes.

• SOP and associated document approvals

• QMS Review and closure

• Undertakes such other reasonable duties as may be required from time to time to support the department and business activities.

• Acknowledges responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives.

Competencies

• Responds promptly to requests and concerns

• Complete business objectives

• Ensure behaviors follow company policies and departmental expectations

• Teamwork

• Problem Solving

• Effective Communication

• Customer Service

• Business Awareness

• Time Management

• Coaching / influencing / training skills

Knowledge and Experience

• Typical Years of Experience 1-5 years.

•Minimum Expected Education- Level 6 – Bachelor’s Degree (or relevant on the job experience)

•Additional Information-University degree; typically, a minimum of 1-5 years experience working in a pharmaceutical GMP environment of which, at least 1-3 years experience is in pharmaceutical QA