Compliance Pharmacist (Re-advertisement)

Responsibilities

• 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

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
• Provide mentorship and guidance to pharmaceutical teams

Product Release Management

• Facilitate end to end product release process within production department
• Manage deviations and adhere to daily, weekly targets
• Raise deviations, complete forms and investigations as required, and implement corrective actions
• 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 with priorities
• Ensure CAPA actions are implemented (deviations, CAPAs, Change controls)

Process and System Improvements

• Continuously review processes 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 to comply with 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, primarily 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 processes 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 tasks and integration of multiple variables
• Interrogating information
• Meeting deadlines
• Finalizing output
• Taking action