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

Skills Required
Background/experience

BPharm Degree
1-3 years’ related work experience
Pharmaceutical manufacturing experience
Registration with Pharmacy Council

Specific job skills

Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
Ability to interpret and implement policies, processes and objectives

Competencies

Information gathering
Interrogation Information
Meeting deadlines
Finalising output
Taking action

Requirements
Skills Required
Background/experience

BPharm Degree
1-3 years’ related work experience
Pharmaceutical manufacturing experience
Registration with Pharmacy Council

Specific job skills

Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
Ability to interpret and implement policies, processes and objectives

Competencies

Information gathering
Interrogation Information
Meeting deadlines
Finalising output
Taking action