QA Compliance Manager (Epping) at Aspen Pharma Group

Purpose

• Develop, manage, and monitor quality procedures, standards, and specifications for value streams in compliance with
  regulations.
• Manage and monitor core QA activities for value streams.
• Review and approve in-process QA programs and activities.
• Responsible for Compliance with cGMP activities on site.
• Performance management of direct reports.
  Planning & Processes
• Interpret, implement, and coordinate systems, processes, policies , and procedures contributing to the quality assurance
  for the site.
• Provide input into existing systems, procedures and policies that impact in-process control activities in value stream
  operations and quality for the site.
  Financial & Resource Management
• Provide input into the functional financial plan/ budget based on operational requirements
• Ensure availability and optimal allocation of resources within the department
  People Management & Development
• Implement human resource policies
• Participate in training, coaching, and development for team members
• Develop and implement performance contracts and succession plans
• Manage conflict, disciplinary, and safety issues
• Assist with recruitment
  Process Compliance
• Review and approve Deviations and CAPA plans to address systematic issues.
• Review and approve operational changes to SOPs and processes
• Participate in Risk Assessments
• Review and update MBPRs as required
  In Process Quality Management
• Review and approve the process for in-process quality management
• Governance, Risk & Compliance
• Ensure site activities comply with operating guidelines and policies for the organisation and function.
• Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS
  COMPETENCIES
• Planning and organizing. Exceptional attention to detail and accuracy.
• Excellent report writing and document reviewing skills.
• Interrogate information.
• Uncompromising individual integrity and work ethic.
• Exercise interpersonal skills, communication, training and problem-solving skills to optimize team performance.
• Managing performance
• Proven leadership skills, self-driven and motivated.

Requirements

JOB SPECIFICATIONS:

• Minimum requirement BSc, BTech, Degree in Natural Sciences or Engineering or equivalent as per the National
  Qualifications Framework
• 5 years of related work experience in a laboratory or preferably chemical manufacturing operation.
• Pharmaceutical manufacturing experience.
• Computer proficiency in MS Office and SAP.