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Production Pharmacist Johannesburg - South Africa

Vela Personnel

Purpose: A multinational pharmaceutical company is seeking a Production Pharmacist who will be responsible to ensure: Safety by ensuring OHS (ACT) Compliance, no fatalities occur on-site, no LTI incidents, and no critical /major findings Efficiency by process standardisation, developing robust products, capacity creation, and reduction of cycle time Quality by obtaining SAHPRA site compliance, QMS /Cipla compliance, maintain RFT process/documents standards, and have no critical/major findings post inspections/ audits The right people are employed and utilised in the facility such that we have the people with the right skill set, problem-solving abilities, focus on the development of current staff and ensure the staff are performance-driven Overall reduction in site costs with regards to OPEX reduction, waste reduction, ensure RFT batches by reducing OOS, OOT, and deviations, ensure there are no write-offs of batches Assist in new product development and/or technology transfers Key Job Outputs: Financial Effective utilisation of resources to keep processes cost effective Continuous improvement processes planning Participates in developing team goals and objectives, by planning resources, equipment and manpower Conducts shift handover Production plan is updated as required, in accordance with Production Planning Contingency plans for production are generated and implemented as and when required: Be accountable for shift production and translating targets into outputs Forecast possible problem areas and non-conformances that could potentially affect production Reporting breakdowns and stoppages to direct line manager/relevant responsible persons Timekeeping of staff Ensure timeous receipt of materials from stores Ensure timeous receipt of batch manufacturing and batch packaging records Co-ordinate daily production activities Multitask daily production activities in conjunction with required document-based activities Prepare for daily operations to meet daily production outputs Motivate and suggest equipment and process requirements/improvements Operate effectively Ensure areas and equipment are clean and ready for use as per relevant SOP Ensure documentation/materials are checked as per SOP Ensure sign off on process: Declaration of ready and clean for production equipment and areas Authorisation of production documents Initiate operational action to prioritise shift challenges and any non-conformances/deviations that may occur Reporting any deviations and the generation of non-conformance reports and investigations Reporting breakdowns to maintenance Monitor downtimes and problem solves with corrective action Evaluates product yields contemporaneously and reports deviations to Production Manager Ensures product yield complies to limits, if not initiate an investigation, collates reports and discusses with Production Manager Performs calculations such as yields and potency calculations in real time Assists in re-design of manufacturing methods Performs training of staff on SOPs, safety, cGMP related requirements, etc. Initiates changes once approval of change request has been obtained Accountable for product and data integrity Writing up of SOPs Generation and close out of deviations and change controls Conduct regular internal and external audits Review and improve current documents (BMR/BPRs, SOPs, Logbooks, etc.) Drawing up of new BMR/BPRs Plan/organise/conduct qualifications and validation of equipment Assist with New Product Development and related validations Maintenance of training matrix Conduct root cause analysis and process optimisation projects Record Keeping Responsible for ensuring the ‘real time' completion of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR), Log Sheets, SAP Transactions etc. during all production processes (reconcile, audit, queries resolved before QA review Responsible for the timeous completion of non-conformance reports and the initiation and implementation of relevant corrective actions as per stipulated timelines Responsible for the timeous completion of change control requests and the initiation and implementation of relevant actions as per stipulated timelines BMR's and BPR's are reviewed and made current where necessary Cost/Budget Support Orders and controls non-production spend items Participates and supports the implementation of best practices and other continuous improvement initiatives Quality Control Assurance Ensures corrective action is taken to minimise deviations and yield transgressions Prepares, reports and submits deviations and relevant non-conformances reports to QA Ensures that cGMP and SOP procedures are strictly adhered to Monitors quality checks including in-process controls according to SOP, reviews and improves if necessary Responsible for document procedure compliance: Sign-on Completion Verification as per SOP Audit documents before QA review and final signoff/release Safety, health and environmental standards Safety, health and environment problems are identified and reported to the safety representative for rectifying Hazardous situations resolved immediately or reported to Production Manager Report all incidents, near misses, unsafe conditions and unsafe acts to your manager or supervisor Ensure that all hazards and risks are reported immediately Look after your own health and safety and the health and safety of other persons Equipment is available and ready for safe use Incidents/accidents are prevented by effective operating of equipment and machinery and following health, safety and environment procedures Health, safety and environment procedures are adhered to The work area is safe and clean as per relevant SOP SOPs are followed Perform duties stipulated in the OHS Act Sec 8.2i appointment letter Learning and growth Provide ongoing assessment and feedback of development Resolve IR issues Performance issues are accurately identified and action instituted Potential conflict is resolved according to IR procedures Disciplinary action is taken according to the IR policy – in cases of poor performance and inappropriate behaviour by staff Identify development/ training needs of self and team Staff performance is monitored against standards and regular feedback is provided Individual goals are developed and aligned to team goals and roles are clearly defined as per role profile Performance discussions are held regularly to identify learning requirements Training of pharmacists conducting internship and pharmacist manufacturing assistants Core Competencies: Strong leader Ability to organise Motivate the staff Take quick and appropriate action in case of problems Qualifications: Bachelor of Pharmacy (BPharm) Experience: Minimum of 2 - 3 years of experience in Pharmaceutical manufacturing plant Previous staff management is advantageous Salary: Market Related Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful. All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013 Apply Now
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