Posting ID: JP-002663853
Independently assess various tasks associated with the disposition of the batch as assigned. Deviations CAPA Batch record review Annual product review QC data and OOS review Engineering Change Controls Document Change Controls C of A generation for clinical and commercial product release Updating of SOPs Material Review Reports Interaction with contract testing labs. Maintain a regular presence on the operation floor working with OPS team leads to review batch records on the floor and assess the state of daily events. Work with Operations to resolve minor events quickly. Report major/critical observations back to QA manager for assessment. Support Engineering, Maintenance, and Production technical needs by reviewing PMs, Calibration documents, function tests, work orders, and other documentation as needed. Release API batches after QA Manager review. Review and release raw materials based on internal QC test results. Back up activities of Quality Systems which includes supporting supplier audits, change control, CAPA, complaint handling, document control systems, and cGMP training of employees. Ensure Quality System, cGMP and ICH guidelines are followed on site. Participate in annual analysis of upgrades to Quality System in terms of both Operations efficiency, as well as new FDA or ICH regulatory changes. Partner with Regulatory Affairs, Project Management, Manufacturing, Development, Marketing as well as Corporate Quality on customer projects, regulatory submissions, and harmonization of PPL Group’s Global Quality standards across PPL Group sites. Performs any and all additional duties as required for this position.
GMP, document control, batch records, drug discovery, Batch record, Quality control, Inspection, Cgmp, Raw material, QMS system
Top Skills Details:
GMP, document control, batch records,drug discovery
Additional Skills & Qualifications:
o Doesn’t want someone they will have to train too much o Just needs some QA experience o 2-3 years minimum of experience o Need industry (drug manufacturing) – this is a different regulatory system compared to med device (they don’t want med device, still open to med device but drug discovery is better) o detail-oriented o quick with patterns o adaptable o problem solver o Quick thinker o quick summary on release with customer results (summarizing the results of the test) o some QC experience or reviewing qc data o tech savvy (quality management system) o QMS system (ASK THIS IN G2) o GMP environment experience Nice to Have o ichq7 experience (code of regulations they use)
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Recruiter: Jennifer Martin