Gmp Training Officer

3 weeks ago

Pinetown, South Africa NBISA Recruitment Full time

**Job Advert Summary**:

- The GMP Training Officer is responsible for the effective development, implementation, management and execution of a competency-based Good Manufacturing Practice (GMP) training program at NBI, in support of NBI’s mission, vision, core values and the quality management system, thereby ensuring organisational compliance with cGMP and regulatory requirements.
- Partner and conduct training needs analysis with key stakeholders to identify training needs appropriate to the individual departmental functions, to initiate and implement a competency-based GMP training program supported by appropriate and effective post training assessments.

**Minimum Requirements**:

- Relevant qualification in Quality/cGMP
- Relevant Training Qualification
- Minimum of 5 years’ experience in a pharmaceutical manufacturing or quality assurance environment, with working knowledge of cGMP, pharmaceutical facilities, processes, equipment and systems.
- Must possess knowledge of adult learning theory, instructional design and effective training methodologies Computer literacy (MS Office, Visio, SAP, Internet).
- Thorough knowledge of cGMP principles is important.
- At least 2 years’ experience in a Training role
- Post Basic PMA preferred

**Duties and Responsibilities**:
**Implementation and maintenance of competency-based cGMP training system that meets business and regulatory requirements**
- Design a framework for implementation and maintenance of a competency-based cGMP training program at NBI.
- Identify cGMP training needs in Manufacturing (Operational departments) and other areas through detailed task analysis, appraisals and consultations.
- Collaborate with the CAPA Officer, Internal Auditor and compliance team to identify cGMP gaps and design training accordingly.
- Ensure that the cGMP training matrix for each department is appropriate and adequate and in line with the departmental functions.
- Develop an appropriate cGMP module for induction of new staff
- Provide guidance and inputs to managers and document compilers when drafting cGMP competency assessment questionnaires.
- Keep up to date with developments and methodologies in workplace learning and training by reading relevant journals, standards and guidelines, going to meetings and attending relevant courses.

**Execution of Training related Administrative requirements independently and in conjunction with relevant stakeholders where required.**
- Amend and revise programmes and training content as necessary, in order to adapt to changes occurring in the work and regulatory environment.
- Consult and collaborate with department supervisors and managers to devise an appropriate training schedule that meets the training requirement with mínimal impact to routine operations.
- Collaborate with the Learning, Development and Performance Management Division to schedule training events and to ensure personnel training records are up to date.
- Collaborate with the qualified trainers to execute cGMP training in line with the set schedule. Provide or facilitate training in conjunction with the qualified trainers.
- Monitor and review the progress of trainees using assessment tools relevant to each of the competencies.
- Follow up with personnel in case assessments were not successfully completed.
- Manage the competency assessment program, using tools such as Skillogical.
- Manage the training records, in line with current NBI practice and in collaboration with the Learning and Development Team.
- Maintain Training Curricula and training records in an inspection ready state.
- Evaluate effectiveness of GMP training
- Provide statistics and frequent reports on cGMP training and the levels of competency, as inputs to quarterly and annual quality management review meetings.
- Maintain applicable administration procedures, policies and reports to ensure compliance with process and regulatory requirements.

**Quality Assurance General Support**
- Promote and execute the Quality Policy throughout NBI.
- Promote cGMP Training throughout NBI.
- Attend and participate in routine meetings as required.
- Participate in Quality and GMP initiatives
- Training of QA systems

  • Gmp Training Officer

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa NBISA Recruitment Full time

    Job Advert Summary: The GMP Training Officer is responsible for the effective development, implementation, management and execution of a competencybased Good Manufacturing Practice (GMP) training program at NBI, in support of NBI's mission, vision, core values and the quality management system, thereby ensuring organisational compliance with cGMP and...

  • Gmp Auditor

    2 months ago

    Pinetown, South Africa NBISA Recruitment Full time

    **Job Advert Summary**: - To support NBI Mission, vision, core values, quality objectives and quality management system through effective self-inspections and vendor audits. The purpose of the position is to ensure organisational compliance with current GMP, relevant ISO standards and regulatory requirements through an effective audit function. - To ensure...

  • Gmp Auditor

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa NBISA Recruitment Full time

    Job Advert Summary: To support NBI Mission, vision, core values, quality objectives and quality management system through effective selfinspections and vendor audits. The purpose of the position is to ensure organisational compliance with current GMP, relevant ISO standards and regulatory requirements through an effective audit function. To ensure that...

  • Training Coordinator

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa Beier Group Full time

    VACANCYTRAINING CO-ORDINATORwill report to the Training Services Manager and will have amongst others, the following duties and responsibilities:Key ResponsibilitiesDelivery Support: Ensure correct stationery and study material stock availability to facilitate training sessions. Ensure that all travel arrangements are done timeously (flights, accommodation,...

  • Skills Development Facilitator

    2 months ago

    Pinetown, South Africa Customised Training Specialists Full time

    **SDF Job Description** Assist the employer and employees to develop a Workplace Skills Plan which helps with the requirements of Seta. Submit the WSP to the relevant Seta. Advised the employer on the implementation of the WSP. Assist the employer to draft an Annual Training Report (ATR) on the implementation of the WSP. Advise the employer on the quality...

  • Skills Development Facilitator

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa Customised Training Specialists Full time

    SDF Job DescriptionAssist the employer and employees to develop a Workplace Skills Plan which helps with the requirements of Seta.Submit the WSP to the relevant Seta.Advised the employer on the implementation of the WSP.Assist the employer to draft an Annual Training Report (ATR) on the implementation of the WSP.Advise the employer on the quality assurance...

  • Production Team Leader

    4 weeks ago

    Pinetown, South Africa AVI Limited Full time

    **AVI Ltd. **is known for its leading household brands across many categories including: hot beverages, sweet and savoury biscuits and snacks, frozen convenience foods, personal care products, cosmetics, shoes, accessories, and fashion apparel. **NATIONAL BRANDS LIMITED** operates 5 manufacturing sites, offering world class manufacturing facilities in...

  • HR Officer

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa Re|source Consulting Full time

    Our client, a national packaging company, has a vacancy for an HR Officer at their KZN office, based inThere is a possibility that this fixed-term contract may become permanent.KEY PERFORMANCE AREAS Recruitment covering all aspects of the recruitment function (5060% of the role) HR Admin, contracts, new hire documentation, benefits and terminations for wage...

  • Office Admin Lady

    4 weeks ago

    Pinetown, South Africa CARtime SA Full time

    Our workshop in Pinetown KZN (CARtime Head-office) is looking for an experience Office Admin lady. MUST have a valid South African driver's license and at least 10yrs Office Administrator experience. **Requirements**: - A Grade 12 Certificate. - A tertiary qualification at NQF level 6 will be advantage. - Sound interpersonal skills. - Honesty and...

  • Production Supervisor

    4 days ago

    Pinetown, South Africa Futurelink Global Recruitment Full time

    **Introduction** Our manufacturing Client, based in Westmead, is looking for an experienced production supervisor to join their team. **Duties & Responsibilities** Material Control; Responsible for the ordering and receiving of material/component as per the daily production plan. Controlling of material usage variances i.e. input vs output. Returning of...

  • Production Team Leader

    4 weeks ago

    Pinetown, South Africa Pro Talent Full time

    **Summary of job**: Reports directly to the Production Manager. Responsible for planning, controlling and leading production within specific production areas, conducting auditing, quality control and control of packaging and raw materials. Responsible for the requisitioning, printing, and control of labels as and when required. Providing a printing service...

  • Production Team Leader I Pinetown

    3 days ago

    Pinetown, South Africa Pro Talent Full time

    **FMCG only** **Summary of job**: Reports directly to the Production Manager. Responsible for planning, controlling and leading production within specific production areas, conducting auditing, quality control and control of packaging and raw materials. Responsible for the requisitioning, printing, and control of labels as and when required. Providing a...

  • Office Admin Lady

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa CARtime SA Full time

    Our workshop in Pinetown KZN (CARtime Head-office) is looking for an experience Office Admin lady.MUST have a valid South African driver's license and at least 10yrs Office Administrator experience.Requirements: A Grade 12 Certificate. A tertiary qualification at NQF level 6 will be advantage. Sound interpersonal skills. Honesty and integrity. Computer...

  • Production Team Leader

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa AVI Limited Full time

    AVI Ltd.is known for its leading household brands across many categories including: hot beverages, sweet and savoury biscuits and snacks, frozen convenience foods, personal care products, cosmetics, shoes, accessories, and fashion apparel.NATIONAL BRANDS LIMITED operates 5 manufacturing sites, offering world class manufacturing facilities in Isando...

  • Apprentice: Fitter

    2 weeks ago

    Pinetown, South Africa NBISA Recruitment Full time

    **Job Advert Summary**: - Supports GMP compliant manufacture of pharmaceutical products by ensuring maximum online time of process Utility services supplied to Manufacturing. - Learn perform routine maintenance on the machines. - Conduct daily checks on machines and their support services. - Evaluate and facilitate repairs of plant equipment and identify...

  • Maintenance Technician: Instrumentation and

    2 months ago

    Pinetown, South Africa NBISA Recruitment Full time

    **Job Advert Summary**: Supports GMP compliant manufacture of pharmaceutical products by ensuring maximum online time of process Utility services supplied to Manufacturing. Responsible for operation, maintenance, engineering projects, plant improvement, maintenance standby and planning of preventive maintenance activities on processes and process equipment...

  • Group Office Manager

    4 days ago

    Pinetown, South Africa Zungu Civils Full time

    Definition: Office managers ensure that the offices they look after are running effectively on a day-to-day basis. Depending on the size of the organisation, they may be involved in a range of activities, from monitoring health and safety to assisting with HR and payroll tasks. They are often the ‘go-to’ person in an organisation as they work closely...

  • Sales Representative

    2 months ago

    Pinetown, South Africa Dixie Recruitment Full time

    Our client is looking for an experienced Sales Representative specialising in Office Automation to expand their footprint in KZN and offer exciting new deals to existing and new clients. **Minimum Requirements** - Matric, relevant sales qualification - Minimum 5 years technical sales experience in an office automation environment - Contacts in the industry...

  • Health & Safety Officer

    2 weeks ago

    Pinetown, South Africa Boardroom Appointments Full time

    **Minimum Requirements**: - Min N3 Civil, Mechanical or Electrical - A qualification in SHE (Health and Safety) management - 3 years experience as a Safety Officer - Strong technical background - Strong excel and reporting skills**** **Respo**nsibilities**: - Co-ordinate and participate in all Hazard Analyses conducted at KZN. - Communicate and train...

  • Production Supervisor

    1 week ago

    Pinetown, KwaZulu-Natal, South Africa Futurelink Global Recruitment Full time

    IntroductionOur manufacturing Client, based in Westmead, is looking for an experienced production supervisor to join their team.Duties & ResponsibilitiesMaterial Control; Responsible for the ordering and receiving of material/component as per the daily production plan.Controlling of material usage variances i.e. input vs output.Returning of all unused...