Pharmacist PVS-O ( Night Shift)
This job has area/shift responsibility for overall 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 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
Responsible for performing operational compliance tasks e.g. Line Clearance, Line Opening, completing Batch Documentation, Yield Reconciliation, Deviation Investigation, etc.
GMP Compliance: Ensuring compliance to GMP guidelines, SOP's and internal audits; ensuring and confirming that all the equipment's are cleaned, certified and available as per SOP's; assist Production in regulatory bodies audit compliance and readiness; assist/lead non-conformance and audit findings investigations and implement preventative actions.
Evaluating and authorizing batch records before submitting to QA
Raising and investigating (Root Cause analysis) of deviations.
Essential Job Responsibilities:
1.GMP & Compliance:
Ensures products are manufactured to the required quality and compliance standards. 1.1 Ensures that all production activities comply with applicable Pharmacy Act and Medicines Act requirements.
1.2 Monitors compliance against applicable Product Master Specifications and cGMP requirements ensuring batches produced to registered methods.
1.3 Assures 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.
1.4 Ensures compliance to relevant GSK policy and SOP's.
1.5 Liaises with the Production Pharmacist and/or the Responsible Pharmacist regarding all product quality-related issues.
1.6 Signs off all key production steps including, but not limited to signing off Line Clearance checks, Line Opening checks, Additions to the Mix.
1.7 Signs-off (approves) all completed batch manufacturing records
1.8 Initiates and coordinates Quality-related trouble-shooting, problem solving and root cause investigations.
1.9 Coordinates 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
1.10 Performs Level 1 (Self Inspections) and participates in Level 2 (Internal Cape Town Inspection), Level 3 (above site GSK Inspections) and Level 4 (Regulatory) Inspections.
1.11 Supports Validation activities as per the Validation Master Plan including Process Validation, Cleaning Validation, Periodic Product Reviews, etc.
1.12 Initiate, Drive, and Coordinates Customer complaints, CAPA actions, Change Control actions
1.13Supports Validation activities as per the Validation Master Plan including Process Validation, Cleaning Validation Periodic Product Reviews, etc.
1.14Conducts training on the execution of SOPs relating to production activities and cGMP compliance
Acts as the SME for Train the Trainer with reference to all production and cGMP compliance activities.
Manages the implementation of the GSK QMS to ensure compliance with global standards.
2.1 Support and translates Regulatory and GSK QMS requirements into SOPs in the Value stream for operational deployment
2.2 Ensures QMS is correctly interpreted, in place and in use in the Value Stream
2.3 Drives improvement in Quality Culture / Mindset e.g. ZDP participation
2.4 Maintains current manufacturing trends and investigates any potential problems.
2.5 Participates in management reviews as per annual Site Quality Plan.
2.6 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
2.7 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
2.8 Ensure that CtR is achieved and documents are right first time
2.9 Promote Right First Time Quality culture across the Value Stream
2.10 Support Data Integrity Champion in the value stream
2.11 Support or serve eDM Champion in the value stream
3. Environmental Health and Safety (EHS)
Ensures product is manufactured to the required EHS standards.
3.1 Complies with and enforces use of EHS SOPs at operational level
3.2. Complies with and enforces regulations pertaining to dress code and safety equipment at operational level.
3.3. Drives improvement in EHS Culture / Mindset e.g. ZAP participation
Executes Production activities in accordance with agreed supply plan. 4.1 Performs compliance related activities in order to deliver the production schedule.
4.2 Monitor stages of product manufacture and completes and approves all manufacturing and batch documentation.
4.3 Initiates trouble-shooting, problem solving and resolution of any obstacles in achieving agreed supply plan.
4.4 Approves commencement of packing runs after performing line clearance checks.
4.5 Completes and signs off manufacturing / packing documentation
4.6 Investigates reconciliation discrepancies or other quality problems.
4.7 Liaises with Production Pharmacist regards to any quality or compliance problems during manufacture or packing.
4.8 Ensure that batch documentation is send on time to OQ
4.9 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.
5.1 Support day-to-day deployment of the GPS and performance improvement activities at site
5.2 Ensure that GPS is being used to develop the capability of all the Value stream personnel to implement day to day continuous improvement activities.
5.3 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.
5.4 To coach / train the teams in in problem investigation and solving
6.1 Perform all tasks and duties within the GPS framework
6.2 Carries out other relevant non-specific duties relating to the Value Stream
Minimum of B Pharm or BSc Pharm
Registered as a pharmacist with the South African Pharmacy Council
Ideally 5 years experience within a pharmaceutical production environment
Relevant GSK policies procedures, processes and systems.
GMP, QMS, EHS and GPS requirements.
Excellent Interpersonal Skills.
Excellent Organizational Skills
Excellent Communication Skills
Uses Initiative and is self motivated.
Excellent Numeracy and Accuracy Skills
Excellent attention to detail
Ability to trouble shoot and solve problems
Ability to work under pressure to deadline.
Ability to work overtime and shift work if required.
Knowledge: The job holder must have:
* A good understanding and knowledge of Good Manufacturing Principles.
* A good understanding, knowledge and applicability of the Regulatory requirements within a manufacturing environment.
* A good understanding and knowledge of the Site and Value Stream's EHS and QMS requirements.
* A detailed knowledge and understanding of various compliance procedures e.g. Line Clearance, Line Opening, etc.
* A good understanding of the GlaxoSmithKline Production System, the GPS standards and its integrated approach
* Working knowledge of Microsoft packages - EXCEL, POWERPOINT and WORD
The job holder must:
* Balance the demands for supply with that of Regulatory, Quality & Safety requirements - see GSK Judgment Ladder.
* Performs a variety of tactical routines, some of which are diverse, e.g. Line Clearance, Line Opening, etc
This position is highly governed by policy and procedures; however opportunity exists for independent thinking relating to improvement of processes and systems.
* The job holder must be capable of using his own initiative, be progressive in approach and understand his/her limitations in terms of the Regulatory / QMS /EHS requirements.
* Examples including improving existing processes, etc
* Compliance with Pharmacy Act 53 of 1974 and Medicines & Related Substances Act 101 of 1965 requirements
* Ensure manufacturing compliance to GMP, safety (product and personal) and relevant regulatory authorities
* Responsible for producing good quality products safely and escalating problems due to poor performance on specific lines.
Company Details: At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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