Quality Assurance Officer - Compliance

Role: Quality Assurance Officer - Compliance
Location:
Marlow site (Orega, Marlow International Parkway, Marlow SL7 1YL), Hybrid
Duration:
12 Months
Position Description:
Reporting to a Quality Manager, providing day-to-day assistance for commercial QA activities associated with effective running of the site QMS supporting the batch release. The QA Officer will ensure assigned tasks are performed in a timely manner to meet internal standards and all associated international GMP/GDP requirements.
Organizational Relationships:
Reporting to line manager.
Relationship with active EU Qualified Persons (QPs) performing certification
Interactions with the global Quality Assurance team, PGS manufacturing sites, EU testing labs and CMO support group (ESQ), as well as regulatory.
Primary Duties:
• To assist in the maintenance of quality systems including deviations/ exception reporting, change control, supply agreements, document control, quality metrics reporting, and training as determined by the QA Manager
• Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP
• To compile & review Product quality review sets for completeness & compliance to EU GMP, Pfizer internal requirements, and regulatory dossier submissions
• Support in internal audits
• Participate in Quality Risk Management (QRM) assessments
• Project execution and support as required.
• Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
Training & Education Required:
• Basic experience in pharmaceutical manufacturing, distribution, and control measures
• Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial.
• Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
• Able to demonstrate good planning and organizational skills
• Attention to detail and accuracy – able to follow verbal and written instructions (SOPs).
• Quality and process orientation and mindset
• Possession of good verbal and written communication skills
• Ability to accept responsibility and be proactive within defined limits
• Excellent system skills – Word and Excel essential, experience with electronic documentation control systems advantageous.
• Enthusiastic, positive individual driven to meet targets and standards
• High level of self-integrity and ethical conduct
Training & Education Preferred
• Sterile injectable manufacture
• Manufacture of novel dosage forms
• Secondary/outsourced packaging activities
• Global manufacture and supply chains
• New product launches & commercial supply chain
Prior Experience Required:
Experience from a quality-based job role
Prior Experience Preferred:
2-3 years in a GMP environment