Cape Town - We are looking to employ a Production Pharmacist for a Global Pharmaceutical Company to Support production (dispensary, manufacturing, packaging and distribution) processes to ensure these that these processes are compliant, reliable and efficient.
Broad Purpose / Function : Four different pillars to achieve the above goal : Day-to-Day Support : The Production Pharmacist (PP) is responsible to properly support the production area to ensure in-compliance support where needed (e.
g. line opening, line closing)Process Knowledge : The PP has to understand the production processes for which he / she is responsibleThis scopes scientific understanding of the process, knowhow on production equipment within the process and identifying risks to ensure execution in complianceProduct Stewardship : This pillar scopes basically the ownership of the product as well as the GMP documentation in the area of responsibilityThe PP will monitor the processes to ensure they are capable and in control, will lead or coordinate any changes (change controls, transfers, etc) and will lead root cause investigation in case deviations happenThe PP is also responsible to ensure that all processes are qualifiedContinuous Improvement : The PP should lead actions to improve the production processes and achieve leaner and more efficient practicesFor this, the PP will identify improvement areas, evaluate risks and execute following Good Documentation Practices e.
g. Change ControlDuties / Responsibilities : Based on the four pillars : Day-to-Day Support : Ensure that procedures and process within area of responsibility are performed in accordance with relevant Standard Operating Procedures, Work Instructions and current Good Manufacturing PracticesDrive and support close out of all relevant compliance related audit findingsResponsible for performing line-openings and in process checks according to legislative and company requirementsUpdate GMP documents (SOP, WI, PPI and PI etc), as required and train accordinglyEnsure effective communication to all relevant partiesEnsure all production documentation and processes are completed as per cGMP guidelinesInteract with cross functional teams to supportUnderstand process flowUnderstand process controls as well as risksUnderstand technically the product and its compositionUnderstand process / product cost structureSupport training to operatorsProcess KnowledgeProduct StewardshipEnsure GMP, EHS and Quality compliance during the execution of the Plan and all related tasks.
Ensures compliance with work instructions according to the relevant SOP'sInitiate, investigate and close out relevant GMP and SOP compliance related NC, CAPA, Change Controls, Deviations and Customer Complaints.
Support process transfers (in or out)Perform in process audits both planned and ad hoc accordingly to ensure that GMP standards are met and maintained.
Support regulatory with technical documents Continuous Improvement : Drive, contribute and support continuous improvement initiatives of GMP compliance and standards within the department accordingly and together with the management teamAnalyze the process on a routine basis to identify risks or inefficienciesLead the execution of Improvement Projects in the area of responsibilityPlan the implementation of improvement projectsPerform internal assessments in production areas and develop corrective actions to strengthen cGMPQualifications / Experience / Requirements : Registered with SAPC as a qualified Pharmacist.
Active listening, provides constructive feedback, team player, communication skillsDrives accountability in the area of responsibility.
Encourages input from the team on decisionsManagement skillsDeadline and target driven approach and behaviourUser knowledge of Microsoft OfficePlease note only successful candidates who matches the criteria will be contacted