Job title : Compliance Pharmacist (Re-advertisement) (Port Elizabeth)
Job Location : Eastern Cape, Port Elizabeth
Deadline : December 15, 2024
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Description Monitor manufacturing compliance to GMP and statutory requirements Monitor adherence to guidelines, procedures, and document controls Manage Production Pharmacists and PMA's Deliver expected value stream targets as per business requirements Facility GMP compliance Team and process development
Requirements Staff development Train new Pharmacists and PMAs on SOPs in transition period Ensure pharmaceutical and supervisory team training is compliant Oversee staff professional development to ensure team value add is realized Facilitate training sessions as required Mentorship and guidance to pharmaceutical teams Product release management Facilitate end to end product release process withing production department Deviation management and adherence to daily, weekly targets Raise deviations, complete forms and investigations as required and implement corrective action Facilitate incident review process Maintain and update records and systems as required Retrieve supporting documentation and records to facilitate and support query resolution Ensure deviation owner allocation and reallocation in accordance to priorities Ensure CAPA actions are implemented (deviations, CAPAs, Change controls) Process and system improvements Continuously review process impacting manufacturing and release to identify and implement optimization measures to improve efficiency and effectiveness Manage, review, and approve change control programs and deviations / concessions comply to standards and specifications Optimize processes and identify gaps in policies/ procedures Drive CAPA investigations in area of focus Implement and maintain KPIs and trackers supporting business objectives Planning Plan and prioritize own and team daily, weekly, and monthly activities Determine, request, and use resources/ assets optimally Align activities with business and customer product release priorities Stakeholder management Key interface between production and support departments with main interface being with the QA department Customer interface as needed to share information, feedback on open items, retrieve guidance and facilitate priorities GMP Compliance Facilitate and support audit management Enforce and control area compliance (personnel, documentation, process, product) Ensure production process adherence to standards and specifications Enable teams and process to achieve documentation and deviation right first-time targets
Skills Required Background/experience BPharm Degree 1-3 years' related work experience Pharmaceutical manufacturing experience
Specific job skills Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements Ability to interpret and implement policies, processes, and objectives
Competencies Leadership Managing complex task and integration of multiple variables Interrogating information Meeting deadlines Finalizing output Taking action
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