Quality Assurance Manager

Quality Assurance Manager

Position Details

Position Title: Quality Assurance Manager
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants

Closing Date: 7 April 2022

Please take note:
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.

Deltamune (Pty) Limited, an independent centre of excellence, is a South African-based biotechnology company. Our focus is on veterinary health offering vaccines on a commercial scale. Deltamune’s veterinary vaccine range includes registered and autogenous vaccines for poultry, ruminants and other species. Deltamune invites all suitably qualified and experienced candidates to apply for the following vacancy:

Position Purpose

A position is available for a Quality Assurance Manager with a relevant tertiary qualification to design and, implement ISO 9001, GMP and relevant quality and safety standards and evaluate internal production services & products. Exposure to auditing systems, ISO 9001 as well as experience in laboratory equipment maintenance and Health and Safety is essential for this position.

Key Accountabilities:
  • Provide overall leadership for the quality management system, procedures, documentation, and methods to ensure its efficient operation and its compliance with applicable regulations and standards (ISO 9001 & GMP).
  • Implement, obtain ISO certification, maintain, and manage the Total Quality Management System including corrective and preventative action (CAPA) management.
  • Ensure adequate & timely follow-up and closure of CAPA’s by working closely with line managers to assure adequate response to corrective and preventive action requests.
  • In collaboration with the line managers, investigate all customer complaints.
  • Provide overall leadership for the quality department with direct supervision of employees.
  • Report the status of compliance with applicable regulations and standards that relate to studies, operations, and facilities to management.
  • Carry out quality risk assessments and compile a risk management plan.
  • Preparation and execution of audits (Internal and external).
  • Perform annual Quality Management Reviews.
  • Updating, implementing, and improving Standard Operating Procedures relating to all quality assurance processes and reviewing company policies and procedures for compliance.
  • Establishing a Master Validation Plan and compiling validation methods for all critical manufacturing processes.
  • Maintain the Site Master File and Quality Manual.
  • Maintain Staff Competency and Training Master Files.
  • Collaborate and advise management to identify and select processes or projects for inclusion of the continuous improvement and quality/safety related strategy initiatives.
  • Managing and controlling budgets for the Quality Department.
  • Training staff in all relevant areas in order to attain and maintain suitable quality standards.
  • Arrangement for calibration and validation of key equipment within scope of operations.
  • To negotiate and facilitate the development and signoff of Technical Quality Agreements.

Deltamune (Pty) Limited, an independent centre of excellence, is a South African-based biotechnology company. Our focus is on veterinary health offering vaccines on a commercial scale. Deltamune’s veterinary vaccine range includes registered and autogenous vaccines for poultry, ruminants and other species. Deltamune invites all suitably qualified and experienced candidates to apply for the following vacancy:

Position Purpose

A position is available for a Quality Assurance Manager with a relevant tertiary qualification to design and, implement ISO 9001, GMP and relevant quality and safety standards and evaluate internal production services & products. Exposure to auditing systems, ISO 9001 as well as experience in laboratory equipment maintenance and Health and Safety is essential for this position.

Key Accountabilities:
  • Provide overall leadership for the quality management system, procedures, documentation, and methods to ensure its efficient operation and its compliance with applicable regulations and standards (ISO 9001 & GMP).
  • Implement, obtain ISO certification, maintain, and manage the Total Quality Management System including corrective and preventative action (CAPA) management.
  • Ensure adequate & timely follow-up and closure of CAPA’s by working closely with line managers to assure adequate response to corrective and preventive action requests.
  • In collaboration with the line managers, investigate all customer complaints.
  • Provide overall leadership for the quality department with direct supervision of employees.
  • Report the status of compliance with applicable regulations and standards that relate to studies, operations, and facilities to management.
  • Carry out quality risk assessments and compile a risk management plan.
  • Preparation and execution of audits (Internal and external).
  • Perform annual Quality Management Reviews.
  • Updating, implementing, and improving Standard Operating Procedures relating to all quality assurance processes and reviewing company policies and procedures for compliance.
  • Establishing a Master Validation Plan and compiling validation methods for all critical manufacturing processes.
  • Maintain the Site Master File and Quality Manual.
  • Maintain Staff Competency and Training Master Files.
  • Collaborate and advise management to identify and select processes or projects for inclusion of the continuous improvement and quality/safety related strategy initiatives.
  • Managing and controlling budgets for the Quality Department.
  • Training staff in all relevant areas in order to attain and maintain suitable quality standards.
  • Arrangement for calibration and validation of key equipment within scope of operations.
  • To negotiate and facilitate the development and signoff of Technical Quality Agreements.

Position Details

Position Title: Quality Assurance Manager
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants

Closing Date: 7 April 2022

Please take note:
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.

Specifications

Qualifications:
  • B Pharma degree or any relevant Science related degree
  • Quality Management Qualification
  • ISO 9001 Lead Auditor Certification
Knowledge / Experience:
  • Minimum 10 years relevant experience in pharmaceutical or manufacturing industry (Quality Assurance, Production and Quality Control).
  • Minimum 5 years’ experience in a QA management position.
  • Knowledge of environmental and occupational health and safety legislation.
  • Statistical analysis experience.
  • Management experience, including performance and discipline.
  • Experience in all aspects of Quality Assurance.
  • Experience in all aspects of Health and Safety.
  • Laboratory experience.
  • Proven experience with ISO 9001 implementation and certification.
  • Proven experience in the implementation of validation protocols.
Skills / Attributes / Competencies:
  • Strong oral and written communication skills with good knowledge of MS Office.
  • Excellent interpersonal skills, including flexibility and the ability to work well in a team environment.
  • Problem Solving Skills with focus on detail.
  • Ability to work independently.
  • Ability to work under pressure and within tight deadlines.
  • Ability to schedule work according to priorities.
  • Willingness to work overtime to meet deadlines.
Special working conditions:
  • Candidates must be healthy and be able to periodically work in rooms that require specialized manufacturing and biocontainment protective gowning and equipment.
Qualifications:
  • B Pharma degree or any relevant Science related degree
  • Quality Management Qualification
  • ISO 9001 Lead Auditor Certification
Knowledge / Experience:
  • Minimum 10 years relevant experience in pharmaceutical or manufacturing industry (Quality Assurance, Production and Quality Control).
  • Minimum 5 years’ experience in a QA management position.
  • Knowledge of environmental and occupational health and safety legislation.
  • Statistical analysis experience.
  • Management experience, including performance and discipline.
  • Experience in all aspects of Quality Assurance.
  • Experience in all aspects of Health and Safety.
  • Laboratory experience.
  • Proven experience with ISO 9001 implementation and certification.
  • Proven experience in the implementation of validation protocols.
Skills / Attributes / Competencies:
  • Strong oral and written communication skills with good knowledge of MS Office.
  • Excellent interpersonal skills, including flexibility and the ability to work well in a team environment.
  • Problem Solving Skills with focus on detail.
  • Ability to work independently.
  • Ability to work under pressure and within tight deadlines.
  • Ability to schedule work according to priorities.
  • Willingness to work overtime to meet deadlines.
Special working conditions:
  • Candidates must be healthy and be able to periodically work in rooms that require specialized manufacturing and biocontainment protective gowning and equipment.
Apply Now

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