Job Description

Overview:
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.
Responsibilities:
Planning and Procedures
?Plan and prioritise daily, weekly and monthly activities
?Determine, request and use resources/ assets optimally
Inspections and Verifications

• 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

Line & Production processing
? Perform, review and approve line sign-on's, closures and clearance authorisations
?Perform, review and approve batch reconciliations to product specifications and quality
?Ensure production process adherence to standards and specifications
Process and system improvements
?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
Compliance & Auditing
?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
Troubleshooting
?Investigate deviations and concessions, and assess risk
?Raise deviations and implement corrective action
?Raise maintenance notifications as and when required
Training and technical expertise
?Train new Pharmacists and PMAs on SOPs in transition period
?Identify refresher or awareness training needs
Administration & Record keeping
?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

?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
?Information gathering
?Interrogating information
?Meeting deadlines
?Finalising output
?Taking action

Skills Required