Validation Lead: Process

2 months ago

Cape Town, South Africa ABC Worldwide Full time

Qualifications required:

 

  • Degree or diploma in Engineering / Natural Sciences / Microbiology or equivalent.

 

Necessary Experience and Industry Accreditation/Knowledge

 

  • At least 5 years’ experience in pharmaceutical/ biotech manufacturing industry.
  • At least 1 to 2 years’ experience at junior to Senior Management level.
  • Experience in quality management systems within a cGMP facility.

 

Key Duties and Responsibilities

 

  • Management and mentorship of Senior Validation Scientists, Validation Scientists and Validation Interns.
  • Ensuring that Validation requirements are achieved at the required quality and regulatory levels (Company, SAHPRA, WHO, pharmacopoeia) and within the agreed timeframes.
  • Conduct section planning and execute activities within own scope of accountability.
  • Ensure adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.
  • Role profiling, goal setting and performance management of Validation staff within the section.
  • Review and/or update high level validation and qualification guidance documents, such as VMP, VPs, SOPs.
  • Attend and participate on technical and projects strategic meetings/discussions involving internal and external stakeholders.
  • Assist in execution of routine qualification activities i.e. Equipment / Utility / Facility, Systems, CSV and Data Integrity.
  • Review and approves protocols and reports for all process validation activities based on company standards/guidelines, procedures, and
  • Industry current practices.
  • Reporting on key operations, critical numbers and key performance indicators that impacts the section’s short, medium- and long-term objectives.
  • Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.
  • Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.
  • Ensure execution of process validation activities including Process Development, Process Validation, Cleaning Validation, Cold Chain and Ongoing Process Verification.
  • Participate in Process Automation and Data Management activities including Data Integrity and CSV.
  • Report timeously on validation progress and status to the Validation Manager.
  • Ensure and or assist system/ equipment owners with identifying maintenance and calibration requirements.
  • Ensure relevant OOS and OOT investigation non-conformances/ deviations, change controls and CAPA’s are initiated and completed.
  • Tracking and expediting the review and sign-off of validation documentation.
  • Writing / guiding the writing of departmental procedures required for qualification.
  • Represent Validation department during internal and 3rd party audits wrt process validation requirements by interacting with auditors.
  • Ensures compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
  • Identify and report any potential risks associated to the process validation activities and address all QMS actions.
  • Continuously build and support a sound quality assurance culture aligned to cGMP within the company.

  • Validation Lead: Process

    3 weeks ago

    Cape Town, Western Cape, South Africa ABC Worldwide Full time

    Job Title: Validation Lead: ProcessAt ABC Worldwide, we are seeking a highly skilled and experienced Validation Lead: Process to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our processes meet the highest standards of quality and regulatory compliance.Key Responsibilities:Management and mentorship of...

  • Validation Lead: Process Optimization

    1 month ago

    Cape Town, Western Cape, South Africa ABC Worldwide Full time

    {"title": "Job Description", "content": "Job SummaryABC Worldwide is seeking a highly skilled Validation Lead to join our team in the pharmaceutical industry. The successful candidate will be responsible for ensuring that validation requirements are met at the required quality and regulatory levels, while also managing and mentoring a team of validation...

  • Validation Lead

    5 months ago

    Cape Town, South Africa Biovac Full time

    **BIOVAC** is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Validation Lead to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Degree or diploma in Engineering / Chemistry/ Natural Sciences /...

  • Process Development Scientist

    4 months ago

    Cape Town, South Africa Watchmaker Genomics Full time

    **Responsibilities** - Validation life cycle management: Managing the entire life cycle of validation activities from initial planning through post-execution review and maintenance of validated status Implement and manage execution of the company validation program: - Develop and implement the validation strategy - Coordinate validation activities with...

  • Validation Lead: Qualification Expert

    1 month ago

    Cape Town, Western Cape, South Africa ABC Worldwide Full time

    {"title": "Validation Lead: Qualification Expert", "content": "Job SummaryWe are seeking a highly skilled Validation Lead to join our team at ABC Worldwide. As a key member of our Qualification and Validation department, you will be responsible for ensuring that our facilities and equipment meet the highest standards of quality and regulatory compliance.Key...

  • Validation Lead: Qualification Expert

    1 month ago

    Cape Town, Western Cape, South Africa ABC Worldwide Full time

    Job Title: Validation Lead: QualificationAt ABC Worldwide, we are seeking a highly skilled and experienced Validation Lead: Qualification to join our team. As a key member of our Validation department, you will be responsible for ensuring that our qualification processes are executed efficiently and effectively, meeting the required quality and regulatory...

  • Validation Lead: Qualification

    2 months ago

    Cape Town, South Africa ABC Worldwide Full time

    Qualifications Required:Degree or diploma in Engineering / Natural Sciences / Microbiology or equivalent. Necessary Experience and Industry AccreditationAt least 5 years’ experience in pharmaceutical/ biotech manufacturing industry.At least 1 to 2 years’ experience at junior to Senior Management level.Experience in quality management systems within a...

  • Electrical Lead Engineer

    2 weeks ago

    Cape Town, South Africa Lead Discovery GmbH Full time

    Triz Engineering Solutions is looking for an Electrical Lead Engineer to form part of our engineering team, with the ability to fit into the DNA of our company culture that is dynamic and embraces change. Apart from a contained and well-rounded person with a high EQ level, he/she will be required to deal with complexity in a fast-paced environment. The...

  • Stability and Validation Engineer

    3 weeks ago

    Cape Town, South Africa Bbisolutions Full time

    Great vacancy Stability and Validation Engineer hiring now Job Details: Stability and Validation Engineer Full details of the job. Vacancy Name: Stability and Validation Engineer Vacancy No: VN437 Basis: Permanent Work Location: Cape Town Job Description The Stability & Validation Engineer is part of the Cape Town team & Global Quality Validation...

  • Senior Validation Manager

    1 month ago

    Cape Town, Western Cape, South Africa ABC Worldwide Full time

    {"title": "Validation Process Manager", "content": "Job SummaryABC Worldwide is seeking a highly skilled and experienced Validation Process Manager to join our team. As a key member of our quality assurance department, you will be responsible for ensuring that our validation processes meet the highest standards of quality and regulatory compliance.Key...

  • Digital and Process Lead

    1 month ago

    Cape Town, South Africa Helderberg Personnel cc Full time

    Key Responsibilities: Lead the integration and updating of systems, emphasizing Accounting and Reporting platforms, to ensure seamless operations and accurate financial reporting. Identify opportunities to streamline processes and workflows, leveraging digital solutions and automation where applicable. Collaborate with Accounting and other business leads to...

  • Process Engineering Lead

    4 months ago

    Cape Town, South Africa Elchemie Full time

    **Water Treatment company based in Cape Town region, has a vacancy for a Process Engineering Lead (Wastewater). BSc/BEng/Masters in Chemical/Water Treatment and a minimum of 4 years experience in wastewater treatment products and services, focusing on wastewater design and implementation required. The Process Engineering Lead must design an optimal, in as...

  • Process Development Supervisor

    4 weeks ago

    Cape Town, Western Cape, South Africa SA Metal Group (Pty) Ltd Full time

    Process Development SupervisorSA Metal Group (Pty) Ltd is seeking a highly skilled and experienced Process Development Supervisor to join our Melt Shop team. As a key member of our operations team, you will be responsible for optimizing and improving our manufacturing processes to ensure high-quality products and efficient production.Key...

  • Process Development Supervisor

    2 weeks ago

    Cape Town, Western Cape, South Africa SA Metal Group (Pty) Ltd Full time

    Process Development SupervisorSA Metal Group (Pty) Ltd is seeking a highly skilled and experienced Process Development Supervisor to join our Melt Shop department. The successful candidate will be responsible for optimizing processes and improving plant efficiency.Key Responsibilities:Support and assist the Melt Shop Manager in achieving departmental goals...

  • Process Development Supervisor

    1 month ago

    Cape Town, Western Cape, South Africa SA Metal Group (Pty) Ltd Full time

    Process Development SupervisorSA Metal Group (Pty) Ltd is seeking a highly skilled Process Development Supervisor to join our Melt Shop team. As a key member of our operations team, you will be responsible for optimizing and improving our manufacturing processes to ensure high-quality products and efficient production.Key Responsibilities:Support and assist...

  • Senior Technical Lead

    1 month ago

    Cape Town, Western Cape, South Africa ABC Worldwide Full time

    Job Title: Senior Technical LeadABC Worldwide is seeking a highly experienced Senior Technical Lead to join our team. As a key member of our technical leadership team, you will be responsible for leading the design, execution, and delivery of complex technical projects within our sterile pharmaceutical manufacturing environment.Key Responsibilities:Develop...

  • Process Development Supervisor

    4 months ago

    Cape Town, South Africa SA Metal Group (Pty) Ltd Full time

    **PROCESS DEVELOPMENT SUPERVISOR, MELT SHOP** **SA STEELWORKS** Responsibilities will include, but are not limited to: - Support and assist the Melt Shop Manager - Manage and maintain an acceptable quality of work performed - Provide Technical/process expertise and leadership - Attend and participate in Production and Engineering meetings when necessary -...

  • HR Business Partner

    6 months ago

    Cape Town, South Africa Lead Capital Group Full time

    **Role Purpose** **HR Strategic Planning** - Provide management oversight and leadership. - Develop an HR strategy for the business which is in line with the organizations, goals and objectives. - Develop and implement a manpower planning helping the new/existing staff to have the needed staff with the right competence on time. - Devise and implement...

  • High Ticket Sales Closer/business Development

    1 month ago

    Cape Town, South Africa Lead Generation Group Full time

    Are you a seasoned sales professional who thrives on engaging in detailed conversations with qualified leads? Lead Generation Group is on the lookout for a High-Ticket Sales Closer / Business Development to join our dynamic team. If you're accustomed to selling high-ticket services and relish the challenge of getting into the weeds with prospects about what...

  • High Ticket Sales Closer/business Development

    2 months ago

    Cape Town, South Africa Lead Generation Group Full time

    Are you a seasoned sales professional who thrives on engaging in detailed conversations with qualified leads? Lead Generation Group is on the lookout for a High-Ticket Sales Closer / Business Development to join our dynamic team. If you're accustomed to selling high-ticket services and relish the challenge of getting into the weeds with prospects about what...