- Monitor manufacturing compliance to GMP and statutory requirements
- Monitor adherence to guidelines, procedures and document controls
- Deliver expected productivity targets as per business requirements
- Related administrative tasks
- Serve as back up to Team Leader on shift
- Plan and prioritise daily, weekly and monthly activities
- Determine, request and use resources/ assets optimally
- Verify schedule 5 products
- Verify certified clean status of rooms and equipment
- Verify, review and approve verification of measuring equipment performance, calibrations and sampling, and dispensing of materials
- Perform, review and approve line sign-ons, closures and clearance authorisations
- Perform, review and approve batch reconciliations to product specifications and quality
- Ensure production process adherence to standards and specifications
- Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
- Manage and resolve customer complaints
- Optimise processes and identify gaps in policies/ procedures
- Drive CAPA investigations in area of focus
- Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
- Verify good document practice as per SOP and regulation
- Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
- Verify IPCs are in line with product quality and specifications
- Review and approve preliminary batch records
- Audit logbooks and systems
- Investigate deviations and concessions, and assess risk
- Raise deviations and implement corrective action
- Raise maintenance notifications as and when required
- Train new Pharmacists and PMAs on SOPs in transition period
- Identify refresher or awareness training needs
- Complete batch records and labels
- Complete deviation forms as required
- Query documents and sign off declarations
- Perform and verify calculations in BMR
- Maintain and update records and systems as required
- Retrieve supporting documentation and records to facilitate and support query resolution
- Bachelors degree in Pharmacy
- 1 to 3 years related work experience
- Pharmaceutical manufacturing experience
- Registration with Pharmacy Council
- Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
- Information gathering
- Interrogation Information
- Meeting deadlines
- Finalising output
- Taking action
