Document Reviewer

Cipla Africa; Durban; On-site; ZAR 200 000 - 300 000; Full time

Job summary

An established industry player is seeking a detail-oriented professional to oversee batch document reviews and ensure compliance with cGMP standards. This role involves managing documentation flow, training staff, and facilitating communication between quality assurance and production teams. The ideal candidate will have experience in a pharmaceutical manufacturing environment and possess strong computer literacy skills. Join a dynamic team where your contributions will help maintain high-quality standards and ensure the smooth operation of production processes.

Qualifications

• Minimum 2 years in a pharmaceutical manufacturing environment.
• Experience in administration within a pharmaceutical setting is required.

Responsibilities

• Ensure real-time completion of Batch Packaging Records and related tasks.
• Manage documentation flow and liaise between QA and Production.

Skills

Document Review

Batch Packaging Records (BPR)

Quality Assurance (QA)

Training Coordination

Computer Literacy

Education

Matric / Grade 12

Pharmacist Assistant (Basic / Post Basic)

Tools

SAP

PA Performer

Job description

To ensure optimal batch document and related documents review and updates in accordance with cGMP and execute all relevant administrative tasks.

Accountability Cluster

1. Record Keeping: Responsible for ensuring the 'real time' completion of Batch Packaging Records (BPR), Log Sheets, SAP Transactions etc during all production processes.
2. Reconcile, audit, and resolve queries before QA login. BPR's are reviewed and made current where necessary.
3. Management of Documentation Flow: Management of documentation (BPR, Protocols etc) i.e., from audit packaging to QA logging. Management of query documentation returns from QA / Production / Stores / Support personnel.
4. Capturing of all Production info (Stats, data, line dairies etc on relevant programs e.g., PA Performer daily).
5. Training of all staff and coordinating training activities.
6. Writing of SOP's.
7. Liaise between QA and Production as an interface regarding priority documents for finished product release to ensure supply chain continuity.
8. Review and improve current and new documents (BPR, Protocols etc).
9. Assist in drawing up of documents (BPR and Protocols).

Key Interactions

1. Procurement team – availability of sundry items.
2. Packaging team – supply of products for packing according to the pack plan.
3. Planning – Clarification and guidance on changes to the production and dispatch plans.
4. Environment and Safety – Compliance to legislation.
5. Quality control and Quality Assurance – Finished product sampling and maintaining cGMP and supply of audited batch documents.
6. Vendors – liaises with service providers and vendors on services, sundries, equipment and utensils.

Key Decisions

1. Document review prioritization based on dispatch schedule.
2. GMP and Quality observations.
3. Safety observations.
4. Continuous improvement idea generations.
5. Staff training and development.
6. Safety improvement.

Minimum Requirements

1. Matric / Grade 12.
2. Pharmacist Assistant (Basic / Post Basic) will be advantageous.
3. Computer Literacy.
4. 2 years in a pharmaceutical manufacturing environment.
5. 1 year administration in pharmaceutical environment.