Quality Assurance Associate
hace 5 días
Slough
Contract: 9-month initially, with possibility of extension Location: Fully on-site in Slough Company: A global pharmaceutical company Job Description Role Purpose & Scope • Join the QA Operations Documentation Control Team, supporting quality assurance activities across the organization., • The primary responsibility is to perform batch consolidation (auditing) for QC Biochemistry and QC Microbiology testing related to Drug Product (DP) and Drug Substance (DS)., • This role involves coordinating QC testing documentation and independently verifying that all required activities are completed and release specifications are met., • Proactively issue GMP documents and labels to Manufacturing in line with scheduled timelines provided by internal departments. Key Responsibilities • Collaborate with internal teams to gather necessary information and maintain strong interdepartmental communication., • Support continuous improvement initiatives within QA quality systems and processes., • Identify and implement enhancements in safety, GMP compliance, and operational efficiency., • Conduct batch consolidation for QC Biochemistry and Microbiology testing of DP and DS., • Prepare documentation for audits and provide consolidated QC data during customer and regulatory inspections., • Contribute to projects aimed at maintaining and improving QA systems., • Apply quality procedures to identify non-conformances and assist in resolving issues., • Issue approved GMP documents for Manufacturing, ensuring accuracy and adherence to deadlines., • Print and verify labels for manufacturing use, including finished product labels., • Issue GMP-compliant logbooks as required., • Manage quality records such as Deviations, CAPAs, Change Controls, and Investigations., • Author, review, and approve GMP documentation., • Prioritize tasks to meet critical deadlines., • Maintain training compliance, ensuring all required modules are completed before performing assigned duties., • Perform additional tasks as required. Key Stakeholders • Quality Control, • Manufacturing, • Quality Assurance and Qualified Persons (QPs) Required Skills & Competencies Skills • Proficient in MS Office (Word, Excel, Access, Outlook) and database systems, • Strong verbal and written communication, • Risk-based decision-making capabilities, • Familiarity with Pharmaceutical Quality Systems (PQS), • High attention to detail and accurate data entry, • Effective workload prioritization and scheduling, • Ability to meet strict deadlines, • Strong organizational and planning abilities Competencies Agility • Learns from experience and adapts to change, • Understands strategic goals and contributes to business success, • Actively participates in team efforts, • Understands customer needs and acts on feedback, • Delivers goals consistently while monitoring KPIs, • Takes ownership of safety and personal development, • Fosters a positive and dependable team environment Qualifications Education • Prior experience in QA and GMP environments, • Strong attention to detail and accurate data entry skills required