Validation Manager
Cape Town,Western Cape,South Africa,
6d ago
  • Job facts

    Direct the Validation Program

  • Develop, implement and maintain the site Validation Program to bring and sustain the company’s systems and policies into compliance with ISO13485 and relevant 3rd party validation requirements.
  • Manage the site validation program and activities for manufacturing and testing equipment, utilities and facilities qualification, computerized systems validation, shipping validation, cleaning validation, test method validation, scale-
  • up / product technical transfers, and process validation.

  • Identify validation gaps, develop and implements Validation plans to ensure a state of compliance is maintained using a risk-based approach.
  • Identify and manage continuous improvement efforts with the objective to achieve quality, reliability and cost improvements.
  • Manage and track the execution of validation activities versus the validation plan and / or project timelines to meet company goals.
  • Track and report metrics related to validation / qualification activities.

  • Manage, coordinate, and plan the work of the department and contract resources. Assess workload and managing departmental / cross-
  • functional resources to achieve departmental goals and validation projects.

  • Schedule, plan, and manage Validation activities / projects including management of the development, completion, logging, and archiving of Validation documentation.
  • Writing and review of procedures and policies required for the validation program.
  • Develop Validation procedures that interpret and apply regulatory (where applicable) requirements concerning validation activities and present the validation approach to peers, management, and regulatory authorities as required.
  • Observe and evaluate processes to make appropriate decisions on issues relating to the validation program adherence and improvement.
  • Act as an advisor to direct reports and customers / stakeholders to meet schedules and / or resolve technical problems.
  • Ensure the Qualification / Validation programs are technically sound.
  • Ensure that the Master Validation Plan and Site Validation Plan are up to date.
  • Ensure that progress against the Validation Plan is visible to the business.
  • Support the maintenance and Calibration programs
  • Financial Control

  • Validation budget control.
  • Obtain quotes for Validation related costs from Suppliers and negotiate pricing.
  • Provide input into the department budget. Establish and report applicable department metrics that drive accountability.
  • A good understanding of resource allocation and forecasting
  • Communication

  • Communicate the status of the validation program to the company and relevant 3rd parties.
  • Communicate with departments with validation planning
  • Communicate any validation related delays / issues / changes to customers, stakeholders, senior leaders, etc.
  • Training

  • Ensure that adequate technical training is provided to the validation team and business on all Validation related procedures and requirements in order to foster high-performance teams.
  • Document Review

  • Review validation related protocols and procedures written by the validation team members and / or departmental staff.
  • External Audits

  • Primary liaison for site validation and participate as required in regulatory and / or customer inspections.
  • Corrective Action

  • Active involvement in CR / NCR / CAPA / RCA process investigations related to qualification and validation.
  • Change Management

  • Ensure that any changes to the business that may impact Validation are risk assessed and, if implemented, tracked for additional Validation actions to take place following implementation.
  • Relationship

  • Establish, nurture and maintain good working relationships with internal and external customer / stakeholders through regular communication, networking and attending relevant meetings.
  • Partner with the Roche validation network to strengthen the Validation program and to foster the exchange of ideas and best practices.
  • Team Culture and Performance

  • Build a team culture of excellence, exceptional work ethic, the superior quality of work and collaborative team spirit.
  • Employee Satisfaction

  • Coach, mentor and provide direction to the team in all aspect of their job performance and career development including training, feedback, rewards and remedial action
  • Recommending appropriate measures to address continuous improvement opportunities.

    Formal Training / Education :

  • Masters in Engineering or Scientific discipline;
  • Certificate in a scientific discipline and a minimum of 10 years’ experience within validation preferred
  • Experience :

  • Minimum of 8 years in a similar role; 10 years preferred in a similar role
  • Knowledge, Skills, and Abilities :

  • Working knowledge Diagnostics and / or Pharma would be preferred
  • Working knowledge of ISO Quality Management systems and Diagnostics would be preferred
  • Highly self-motivated, have excellent organization and able to communicate effectively at all levels in verbal and written form, including technical / business writing.
  • Able to establish and manage multiple cross-functional teams simultaneously.
  • Willing and able to work independently and as part of a multi-disciplinary team.
  • Comfortable with change and be willing to establish and work towards the future vision of the organization
  • Personal Skills : Drive to achieve, Attention to detail Initiative, Planning & Organizing, Adaptable, Effective time management, Assertive.
  • Interpersonal Skills : Critical Thinking, Team player, Communication, Motivating, Flexible, Coaching.
  • Managerial Skills : Mentoring & Coaching, Agility, Accountability, Strategic Thinking, Decision making, Change management, Prioritization, Resource Allocation, Development, Sense of Urgency.

    Possibly up to 5% of International Travel.

  • Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-
  • focused healthcare groups. Our success is built on innovation, curiosity and diversity.

    Roche is an equal opportunity employer.

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