QA Operations Manager & QP

Job description

Job Description Summary The Quality Operations Manager / QP provides oversight of Quality Operations across the site and assures that all batches are released according to registered specifications. The QA operations Manager provides leadership to the team of QA Specialists and Release Responsible Persons/QPs and also acts as the site’s Lead Qualified Person. Job Description: Major Accountabilities: Provide oversight of Quality Operations across site, e.g. inbound and outbound QA oversight, MBR review and approval, product release, QA for QC and AS&T, Production (shop floor presence and collaboration), Engineering (oversight over maintenance, calibration), MS&T (validation activities, life cycle management), QA Operational Excellence. Provide leadership to the team of QA Specialists and Release Responsible Persons/QP. Define resource needs related to the QA operations team. Ensure the team members are open to development and define training needs. Assure that people are trained on time and track additional training needs. Provide input to training needs and assure that the site associates have appropriate GMP training. Lead batch release activities and QP certification of the batch...