Job Description

Job Summary DutiesI Responsibilities:

Monitoring GMP in the plant

• Perform Quality Assurance tasks including production line start up checks, IPCxe2x80x99s e.g. Updated cleaning logs, cleaning status labels and inspect and approve manufacturing/packaging rooms, lines and equipment prior to use.
• Inspect all departments daily, for housekeeping,statuslabels, updated log books etc.
• Identify and report deviations or non-conformances of process, component, or documentation from specifications, standard operating procedures, process instructions and packaging process instructions.
• Audit documentation on line prior to submission to lot release for good documentation practices and specific checks to meet right first time (RFT) measurement.
• Perform and document required in-process checks and challenge testing of product.
• In the case of batches being placed on hold, being responsible for ensuring the goods are labeled and transactions complete.
• First Article Inspections.
• Assist Lot Release with complaint investigation, by gathering required information from the factory (e.g. interviewing staff, checking logs, etc).
• Assist with any investigation in the factory as required.
• Responsible for stopping the line or manufacture, if a serious non-conformance is noted. Report stoppage immediately to Line Management, Area Management Lot Release Pharmacists and Quality Assurance Management.
• Maintain training status as per training matrix and conduct training as required for staff.
• Conduct product acceptable quality level (AQL) inspections on pallets produced should major defects be detected between two testing periods.

Issuing of GMP Documentation

• Review documentation to confirm accuracy, completeness and GMP compliance ensuring, deviations and NC's are reported online.
• Management of document queries between lot release and production.
• On the issuing of official documentation , verify that BOM and Process Instruction, and Packaging Process instructions are current revisions from TRU.
• Ensure issuing logbooks are completed.
• Assist LR in the compilation and supply of CoCxe2x80x99s and CoAxe2x80x99s for external customers timeously where necessary.

Log and Track Samples

• Sample bulk and intermediate products and perform in-process checks routinely we required.
• Sample finished goods products, perform in-process checks.
• Collect, log and file finished goods retention samples.
• Collect, log and forward lot release samples to Lot Release Pharmacists where necessary.
• Collect any additional samples as required by Quality Assurance and Quality Control.
• Perform AOL (Acceptable Quality Level) Inspections when required.
• All samples are taken independently of production staff.

Assist in management of Archive and Stability rooms

• File Samples and documents efficiently.
• Retrieve batch documentation and retained samples when required.
• Ensure out-dated samples and/or documents are destroyed as per the SOP.
• Manage the GMP and ensure archive rooms are maintained and cleaned.

Perform other miscellaneous duties as assigned

Qualifications I Experience I Requirements:
EDUCATION: Grade 12
POST SCHOOL: (Professional Technical/ Academic) Pharmacist Assistant (Advantageous)
EXPERIENCE: 3-5years in a pharmaceutical
environment
Skills:
-Good knowledge and understanding of the SA GMP guide.
-High attention to detail.
-Good planning and administrative competencies.
-Good verbal and written communication skills.
-Logical approach to problem solving and trouble shooting.
-Strong independent working ability.
-High work standards and business ethics.
-A self-motivator with high energy levels xe2x80x93 ability to work autonomously, governed by tight deadlines.

Manpower Group

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