This job has area/shift partial responsibility for compliance oversight and regulatory related activities. Ensures that products are manufactured and packed to the required quality and compliance standards accordance with statutory requirements and duties and ensures Compliance within the Value Stream.
The Pharmacist assistant report directly into Production Pharmacist in the Value Stream. Ensure that applicable Standard Operating Procedures are followed, Monitors adherence to rules, regulations and procedures and help team to achieve business goals. Support the Team in application of GPS basis to promote a culture of continuous process and quality improvement.
Work extended shift during the week and on weekend when operationally required
Performs in-process control checks on product during manufacture and packing
Measure and records temperature and relative humidity readings in the at the GMS Cape Town Facility
1. GMP & COMPLIANCE
Ensures products are manufactured to the required quality and compliance standards.
Assist the Pharmacists to ensure that all production activities comply with applicable Pharmacy Act and Medicines Act requirements.
Assists the pharmacist to monitor compliance against applicable Product Master Specifications and cGMP requirements ensuring batches produced to registered methods.
Assists the pharmacist to Assure the “In Place” and “In Use” status of all GMP systems and procedures relating to the prevention of contamination, cross-contamination, mix-ups and maintenance of good documentation practices.
Liaises with the Production Pharmacist and/or the Responsible Pharmacist regarding all product quality-related issues.
Assists with Quality-related trouble-shooting, problem solving and root cause investigations.
Assists with investigations into quality-related non-conformances including, but not limited to, line clearance failures; yield discrepancies; cGMP non-compliances and non-compliances against Master Specifications
Participates in Level 2 (Internal Cape Town Inspection), Level 3 (above site GSK Inspections) and Level 4 (Regulatory) Inspections.
Supports Validation activities as per the Validation Master Plan including Process Validation, Cleaning Validation, Periodic Product Reviews, etc.
Assists with completion of Customer complaints, CAPA actions, Change Control actions
Supports Validation activities as per the Validation Master Plan including Process Validation, Cleaning Validation Periodic Product Reviews, etc.
Assists with conducting training on the execution of SOPs relating to production activities and cGMP compliance
Tests compliance of products and materials as per documented Product / Material Specifications and Analytical Methods.
Analyses a broad range of product types – all value streams.
Tests performed include physical dimensions (diameter, thickness, disintegration time, friability, hardness etc.).
Performs analysis using wet chemical techniques and instrumental methods of analysis (pH, Density etc.) as applicable.
Examines samples critically and performs on line checks (counts, weights, integrity of sealing etc.).
Assists with the the implementation of the GSK QMS to ensure compliance with global standards.
Support and translates Regulatory and GSK QMS requirements into SOPs in the Value stream for operational deployment
Assists in implementing the QMS and maintaining in place and in use in the Value Stream
Drives improvement in Quality Culture / Mindset e.g. ZDP participation
Maintains current manufacturing trends and investigates any potential problems.
Support Implementation of QMS in all parts of the Value stream ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines
Support the Production Manager/Pharmacist to ensure that the Value stream is always inspection ready with daily and monthly tracking and performance management of all the quality and compliance elements – CAPAs, Deviations, Change Controls, Customer Complaints, Training, SOPs, L1/L2/L3/L4 Audit Findings and Commitments
Ensure that CtR is achieved and documents are right first time
Promote Right First Time Quality culture across the Value Stream
Support Data Integrity Champion in the value stream
Support or serve eDM Champion in the value stream
3. ENVIRONMENTAL HEALTH AND SAFETY (EHS)
Ensures product is manufactured to the required EHS standards.
Complies with and enforces use of EHS SOPs at operational level
Complies with and enforces regulations pertaining to dress code and safety equipment at operational level.
Drives improvement in EHS Culture / Mindset e.g. ZAP participation
Executes Production activities in accordance with agreed supply plan.
Performs compliance related activities under direct supervision of a pharmacist in order to deliver the production schedule.
Initiates trouble-shooting, problem solving and resolution of any obstacles in achieving agreed supply plan.
Performs the initial line opening check prior to the pharmacist approving the start of packing runs
Assist the Pharmacist is performing line clearance checks.
Collates and reviews manufacturing / packing documentation
Manages the PSA and performs the goods issue for components
Investigates reconciliation discrepancies or other quality problems.
Liaises with Production Pharmacist regards to any quality or compliance problems during manufacture or packing.
Ensure that batch documentation is send on time to OQ
Participate in real time problem solving & QRAP
Helping to ensure the day to day continuous improvement activities result in a continuous improvement in the Site Performance towards the goal of Zero Accidents, Zero Defects and Zero Waste.
Support day-to-day deployment of the GPS and performance improvement activities at site
Ensure that GPS is being used to develop the capability of all the Value stream personnel to implement day to day continuous improvement activities.
Helping ensure the day to day continuous improvement activities result in a continuous improvement in the Site Performance towards the goal of Zero Accidents, Zero Defects and Zero Waste.
To coach / train the teams in in problem investigation and solving
Perform all tasks and duties within the GPS framework
Carries out other relevant non-specific duties relating to the Value Stream
Knowledge/ Education / Experience Required
A. Educational Background
1. Minimum Level of Education
Pharmacist assistant Post Basic qualification and Registered as a Pharmacist Assistant Post basic with the South African Pharmacy Council
Why is this Level of Education Required?
It is a Regulatory requirement
2. Preferred Level of Education
Pharmacist Assistant Post basic
B. Job-Related Experience
Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
Minimum Level of Job-Related Experience required
Ideally 5 years’ experience within a pharmaceutical production environment
Why is this Level of Experience Required?
Adequate experience required in the pharmaceutical environment
C. Other Job-Related Skills/Background
Registered as a pharmacist with the South African Pharmacy Council
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