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