Job Description

Overview

Monitor manufacturing compliance to GMP and statutory requirements. Monitor adherence to guidelines, procedures and document controls. Manage Production Pharmacists and PMAxe2x80x99s and 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 prioritiesEnsure CAPA actions are implemented (deviations, CAPAs, Change controls)

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 yearsxe2x80x99 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

Aspen Pharmacare