Compliance Pharmacist (Port Elizabeth) at Aspen Pharma Group

Overview 

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures and document controls
• Deliver expected value stream targets as per business requirements
• Facility GMP compliance
• Team and process development

Responsibilities

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 re-allocation 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
• Optimise 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 prioritise 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

Requirements

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
• Finalising output
• Taking action