Production Pharmacist Assistant at GSK

• 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

Key Responsibilities

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.).

QUALITY

• 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

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

PRODUCTION

• 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