Senior Quality Assurance Specialist – Operations Support
Malta
Full Time
1 hour ago
Visa Sponsorship
Key skills
CommunicationCollaboration
About this role
Role Overview
Review and approve/reject printed packaging materials in a timely manner according to the production plan
Prioritise packaging materials listed in the Exceptions Report and ensure same-day review when entered into XAL
Review and approve printed packaging material specifications, including Version 1 and non-Version 1 documents
Sample printed packaging materials upon request
Compile Certificates of Analysis (CoAs) for printed packaging materials as required
Prepare Batch Release Certificates (Commercial and Registration), including CoAs, BRCs, and CoCs, prior to Qualified Person (QP) review and within agreed timelines
Provide clients with commercial batch documentation, including approved certificates, starting material certificates, and manufacturing/packaging batch documentation as specified in Technical Agreements or product specifications
Coordinate the preparation and distribution of finished product samples, registration documentation, and supporting information required for product registration and business expansion activities
Act as the primary liaison between clients and internal departments for quality-related queries and requests, ensuring responses are provided within 48 hours
Perform training on new or updated Standard Operating Procedures (SOPs) and ensure compliance with authorised SOPs at all times
Maintain and update QA records, databases, and logbooks regularly to support efficient and reliable operations
Archive and retrieve QA batch documentation, logbooks, and packaging material samples as required
Participate actively in projects aimed at improving quality assurance processes and departmental performance
Compile assigned Product Quality Reviews (PQRs) on a monthly basis
Perform additional duties and responsibilities as required by the department
Requirements
Excellent attention to detail and accuracy
Strong customer service orientation
Effective communication and organisational skills
Proactive, reliable, and hardworking attitude
Proficiency in Microsoft Office applications
Ability to work under pressure and meet strict deadlines
Strong teamwork and collaboration skills
Diploma-level education
Experience in quality assurance, pharmaceutical operations, packaging review, or a related field is considered an asset