Quality Assurance (QA) Associate

This position is responsible for performing the daily QA activities that support the Quality Assurance department and facilitate the overall EU GMP/GDP compliance of Xerimis Ltd and Xerimis BV., * Assists the Qualified Person in the preparation of QP Declarations and QP Certificates. This will involve creation of supply chain diagrams, product specification files, review of regulatory submission documents and review of manufacturing batch records

• Participates in regular meetings with clients
• Facilitate during a recall by gathering information related to the recall, preparing the necessary documentation and performing accountability
• Assists with the generation, revision and review of Standard Operating Procedures, Data Capture Forms and other GMP/GDP documents
• QA Management of SOPs, Forms, WIs, Position Descriptions and Training Presentation’s on electronic system
• Responsible for internal SOP training of all employees, keeping track of their training and maintaining their training records
• Assist with the creation and delivery periodic GXP trainings
• Performs and/or participates in internal, supplier, client and Regulatory Authority audits as required
• Responsible for reviewing and archiving the preventative maintenance documentation
• Responsible for instrument identification, master list creation and maintenance, calibration file maintenance, calibration frequency, contractor selection and certificate review, handling of out of tolerance investigations, and handling of out of service instruments and retired instruments
• Maintains EU GMP/GDP documentation storage of all pertinent documents, including scanning, filing and archiving (manually & electronically)
• Provides QA support to all GMP/GDP activities including receiving, storing, distributing, returns processing and disposition of products.
• Perform incoming quality control inspection of all materials, if required
• Perform quality control packaging room activities, if required
• Perform quality control activities of Just In Time Shipments, if required
• Verify Returns for Accountability, if required
• Enters and verifies data in Inventory Control System (ICS)
• Participates in the approval of material specifications and other batch record related documents (including packaging samples)
• Provides QA release of products and assists with the proper storage of quarantined and rejected materials
• Provides QA release of clinical labels printed by Xerimis or an approved supplier
• Monitors the tracking and updating of product expiration dates and authorization of materials for destruction
• Performs weekly reviews of all log books
• Participates in investigations and resolution of operational discrepancies and client complaints
• Responsible for reviewing and filing cycle count documentation
• Assists with the maintenance of supplier approval records
• Assists with the development and implementation of the Corrective Actions & Prevention Actions (CAPA) programme; maintains and updates the CAPA tracking system
• Ensures there is a proper change control procedure in place for documentation, processes and systems
• Oversees GMP/GDP risk assessment programme and ensures that the mitigation strategies are identified and implemented
• Obtain and review facility temperature records
• Assists with the implementation of validation activities including annual reviews
• Assist with Quality metrics tracking
• Responsible for review of products that are new to Xerimis Ltd/BV to determine if they are acceptable for handling or use at Xerimis
• Responsible for review and approval of Manufacturer-Generated or Client-Provided Packing Configuration and the qualification reports for the insulated shipping container
• Review and approval of materials pulled for Interoffice Shipping Requests
• Other duties as required

• Related Bachelor’s degree or equivalent
• Excellent reading and writing skills
• English literacy
• Excellent communication skills
• Excellent mathematical skills
• Excellent problem solving/investigational skills
• Strong computer literacy skills
• Strong attention to detail
• Familiarity with GCP in the clinical trials industry
• Strong understanding of GMP and GDP in the pharmaceutical industry
• Strong interpersonal skills
• Effective time management skills
• Ability to work effectively with a wide range of constituencies in a diverse community.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Some physical lifting as required maybe required. While performing the duties of this job, the employee perhaps exposed to the warehouse and operations (packaging) environment including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals. Personal Protective Equipment (PPE) and associated training will be provided.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.