VACANCY: PRODUCTION PHARMACIST

CIRCULAR NO: 053/2021

Date:  03 September 2021

 

NBI is passionate about building a team of high performing individuals who are committed to our purpose of providing products to patients to alleviate pain and suffering and improve their quality of life.

Inspired by our values, we strive nurture a culture that thrives on innovation and collaboration.

Applications are invited from suitably qualified and experienced candidates for the following vacancy.

 

PRODUCTION PHARMACIST

 

Division / Department:                 Pharmaceutical Manufacturing Labour

Position reports to:                         Responsible Pharmacist

Grade:                                              13

 

About the role

This role is responsible for

  • Oversight and authorisation of pharmaceutical aspects of manufacturing processes within NBI, including key steps as identified in the MCD and aligned to the dossier (CTD).
  • Ensuring the safety, quality and efficacy (SQE) of finished products, cognisant of legal requirements, as prescribed by the Medicines Act and Pharmacy Act.
  • Working closely with the Office of the Responsible Pharmacist (ORP), manufacturing managers, and heads of departments to ensure compliance to cGMP.
  • Identification of continuous improvement interventions in work processes and incorporation of these into production documentation and training.
  • Contributing to product and/or process investigation and/or manufacturing projects.

 

Minimum Requirements

  • B Pharm
  • Registered with SAPC
  • Knowledge of GMP principles
  • 2 years post-registration working experience
  • Experience in a pharmaceutical manufacturing environment will be an advantage

 

Specific Operational Requirements

The successful candidate will be required to work:

  • The successful candidate will be required to work an 8 hour shift between 06h00 to 18h00, as rostered.
  • May be required to work overtime to meet the business needs.
  • Must be prepared to work shifts when needed.

 

 

Specific SHE Requirements

  • Pre-employment, routine and exit medicals are compulsory due to the nature of the business
  • Attendance to SHE related training is mandatory.
  • Adherence to SHE Instructions (Waste Segregation, Water and Energy Saving Initiatives)
  • Compliance to SHE Site Rules is compulsory.
  • NBI uses hazardous and biologically active chemicals. The successful candidate will be required to use proper PPE and will go through medical examinations as per OSH Act requirements.

 

Key Performance Areas

 

Pharmacist Authorisations

Responsible for performing all pharmacist authorisation steps within the manufacturing department by:

Performing duties with respect to process authorisations. These include, but are not limited to:

  • independently checking and signing each dispensed material and its mass or volume (e.g. paste & powder mass verification)
  • check and sign the addition of each material to the mix (e.g. addition of viral inactivation reagents)
  • check and sign the identity of the bulk product and printed packaging material;
  • check and sign that each filling or packaging line or station is clear of previous product, packaging components, records or materials not required for the planned filling or packaging operations, and that equipment is clean and suitable for use before any filling or packaging is undertaken.
  • Opening and closing of production lines
  • Verification of expiry date & printing of expiry labels
  • Product formulation
  • Signing for authorisation or verification of production activities, on the relevant documentation at the time the event occurred.
  • Completing and auditing production batch documents before submitting to ORP
  • Perform all required SAP transactions in a timely manner.

The Production Pharmacist (Packing) has the following additional responsibilities:

  • Assists in achieving departmental objectives by completing the tasks below and any related tasks with precision and accuracy and within the defined timelines as dictated by the packing, labelling and inspection plans to meet internal and external customer demands:
    - Pharmacist authorisation and compliance with statutory requirements in ensuring process control during packing, labeling and inspection operations.
    - Assist with ensuring process control, through pharmacist authorisations in other areas of manufacturing, when required.
    - Adhering to SOPs, complying with current Good Manufacturing Practice, Good Pharmacy Practice, OHS Act and other legislation.

The Production Pharmacist (Dispensary) has the following additional responsibilities:

  • Performing duties as outlined, as may be amended from time to time, with respect to dispensary authorisations. These include, but are not limited to:
    - Supervision of manufacturing dispensaries
    - Overseeing and planning all dispensary activities and performing pharmacist authorisations in accordance with the relevant SOPs
    - Line opening and closing for dispensing of materials
    - Verification that the correct mass of raw material in accordance with the master recipe in SAP.
    - Verification that all raw materials required for production have been checked, are batched and labelled correctly prior to being issued to a process order
    - Dispensing of bulk raw materials for the relevant production process

 

cGMP & cGPP Compliance

  • Ensure compliance with the Pharmacy Act, Medicines Control Act and related regulations and guidelines, including the Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) guidelines.
  • Provide pharmaceutical support to the cGMP initiatives identified by ORP as outlined in NBI’s Quality Policy by:
    - Identifying and driving continuous improvement initiatives through performance of regular self-inspections.
    - Ensuring that corrective and preventive actions (CAPA) identified as part of internal and/or external audits are attended to and implemented in a timely manner.
    - Identifying where documentation and systems are lacking in terms of process control and cGMP compliance, and assisting in resolving the deficiencies.
    - Reviewing existing documentation and compilation of new documents to align with existing production processes and facilitate cGMP compliance, taking into consideration the dossier (CTD).
  • Instilling a culture of quality by:
    - Working with due regard to the NBI Quality Policy.
    - Ensuring that any changes or implementation of any new procedures are carried out in accordance with the NBI Change Management policy and procedure.
    - Ensuring that all discrepancies in, or breach of procedure, policy or cGMP is documented in accordance with NBI incident and deviation reporting structure.
    - Participating in validations, as required, in accordance with set requirements.

 

Training

  • To conduct cGMP- related training for personnel in collaboration with ORP and Manufacturing HODs by:
    - Identifying training needs and providing recommendations on the structure and content of any training to be conducted.
    - Liaise with NBI Training Coordinator via ORP to arrange training logistics.
    - Provide pharmaceutical related training to manufacturing staff in conjunction with ORP & HOD.
    - Conducting post training assessments to evaluate effectiveness of training and competency of staff.
    - Training may include, but is not limited to the following:
         On the Job Training
         NBI Policies & Procedures
         cGMP Training
         Relevant SAP Transaction and Process Training (Peers)
         Pharmacists Assistants Training
  • Provide input into the performance of teams by working with HOD’s to identify key performance indicators.
  • Submit Team Performance Reports to HODs and assist with analysis and interpretation.

 

Process Efficiency Monitoring and Product Investigation

  • Conduct assigned manufacturing or product investigations either as lead investigator or as a member of the cross-functional team.
  • Critically evaluate processes with respect to Good Manufacturing Practice (GMP), Good Pharmacy Practice (GPP) and Good Warehousing Practice (GWP).
  • Motivate and support the adoption of process enhancements to departments concerned.
  • Report on outcome of projects to relevant stakeholders, as required.
  • Submit Shift-Handover Reports to relevant stakeholders at the end of each shift.

 

Continuous Improvement Projects

Responsible for the successful implementation of projects that have been assigned by:

  • Using accepted project management tools;
  • Applying principles and knowledge of project management processes such as:
    - Initiating
    - Planning
    - Executing
    - Controlling, and
    - Closure
  • Report on outcome of projects to relevant stakeholders, as appropriate.

 

Core Competencies

  • Technical/Professional knowledge
  • Teamwork/Collaboration
  • Good communication (written & verbal) & interpersonal skills
  • Attention to detail
  • Fact finding and analytical ability
  • Quality orientation
  • Computer literate
  • Integrity
  • Initiative
  • Tenacity

 

In line with the Employment Equity Act, preference will be given to those applicants whose appointment will address the demographic imbalances in our work force profile.

 

Due to the nature of the business, pre-employment, routine and exit medical examinations are compulsory.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013.

To be considered for this position, please email your CV to This email address is being protected from spambots. You need JavaScript enabled to view it. by 17 September 2021 with the name of the vacancy for which you are applying in the subject line.

 

Closing Date:  17 September 2021

If you have not had a response from us within 30 days after the closing date, kindly accept that your application has been unsuccessful.



 

We use cookies on our website. Some of them are essential for the operation of the site, while others help us to improve this site and the user experience (tracking cookies). You can decide for yourself whether you want to allow cookies or not. Please note that if you reject them, you may not be able to use all the functionalities of the site.