Senior QA Associate - Early Shift

Thermo Fisher Scientific
07 Oct 2016
20 Oct 2016
Contract Type
Job Description Job Title: Senior Associate (Packaging), Document Control Reports To: Manager, Document Control Group/Division: BSD Career Band: 5 Job Track : Management Position Location: Horsham Number of Direct Reports: 6 Position Summary The post holder will manage the document control activities to achieve the timely review of EPO and Post Batch records in support of production and in accordance with the QA Packaging Schedule. The post holder will be point of escalation for GxP issues relating to EPO/Post review to ensure timely resolution in support of production and in accordance with the QA Packaging Schedule. Key Responsibilities To manage the workload and priorities on a daily basis for EPO and Post approval stages (and associated tasks) are reviewed to meet Operations timelines Ensure all GPMS issues affecting the approval of batch records are completed with the required timescales Prepares new and reviews existing Standard Operating Procedures (and associated documents) relating to the processes for batch record review to ensure standard working practices. Investigation and review of any complaints or unplanned deviation reports in association with batch record review ensuring documents are completed within the agreed timelines. To ensure any discrepancies are identified and that timely action is taken to remedy the situation referring any issues to the QA Document Control Manager. Acts as initial point of contact for client comments and queries in relation to batch record observations. To assist the QA Document Control Manager in the training of QA Associates (packaging) to ensure adequate training to perform required tasks. Provide input into the recruitment process for QA Document Control team. Provides a point of contact for the team in the absence of the QA Document Control Manager. Minimum Requirements / Qualifications Must be educated to degree level or extensive experience of pharmaceutical GPM Previous working experience in clinical trails Packaging / Distribution Ability to work with a team providing support to other team members Ability to work without direct supervision/own initiative within the remit of the role. A high degree of accuracy and attention to detail Good verbal and written communication Previous experience in a supervisory role is advantageous Team work and co-operation within team and different shifts Problem solving and decision making Good organisational skills