- Monitor manufacturing compliance to GMP and statutory requirements.
- Monitor adherence to guidelines, procedures, and document controls.
- Manage Production Pharmacists and PMAs.
- Deliver expected value stream targets as per business requirements.
- Facility GMP compliance.
- Team and process 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.
- 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 with priorities.
- Ensure CAPA actions are implemented (deviations, CAPAs, Change controls).
- 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.
- 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.
- 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.
- 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
- BPharm Degree
- 1-3 years related work experience
- Pharmaceutical manufacturing experience
- Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
- Ability to interpret and implement policies, processes, and objectives
- Leadership
- Managing complex task and integration of multiple variables
- Interrogating information
- Meeting deadlines
- Finalizing output
- Taking action
