Description

• 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.

Requirements

Planning and Procedures

• Plan and prioritize 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 authorizations
• 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.
• Optimize 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

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