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Quality & Validation Manager
Quality & Validation Manager
The Main Purpose of the Role:
To ensure that the product or service of the organization is fit for purpose, consistent, and meets both external and internal requirements. This includes regulatory compliance, legal compliance, and customer expectations.
Key Duties /Responsibilities:
- Remain up to date with ISO requirements and ensure the company is audit-ready.
- Plan and monitor internal audit schedule.
- Quality system development, implementation & maintenance.
- Ensuring that processes meet with ISO and AS requirements.
- Assessing product specifications and customer requirements and ensuring they are met.
- Agreeing in-house standards for quality.
- Monitoring performance by gathering data and producing reports.
- Supervising the programme of internal auditing and calibration.
- Development, Maintenance, and Approval of Standards.
- Managing quality issues to ensure timely and effective corrective actions to prevent re-occurrence.
- Providing support to Regulatory and Customer audits.
- Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.
- Supplier and Customer Liaison on Quality Issues.
- Provide validation expertise to maintain validated status for the facility.
- Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software, and process, and approve validation documentation.
- Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.
- Coordinate validation activities to ensure schedule adherence and compliance.
- Using statistical analysis, measure, control, and improve product and process robustness.
- Maintain a positive department attitude and ensure that all employees under your supervision are aligned with the company goals.
- Proactively, through the use of team meetings and other communication skills, develop sustainable goals and targets for each team within the area.
- Lead and develop team.
- Conduct Performance reviews, RTW, probation reviews, etc.
- Hire/interview as needed. (Operation manager to have input).
- Discipline as required in line with current procedures.
- Design, maintain, and implement training programmes as agreed with management.
- Manage holiday schedule.
- Housekeeping –Maintain Standards.
- HR Policy -Know and administer HR Policy.
- Health and Safety – Be pro-active in identifying and addressing any health and safety issues that arise.
- Liaise with other departments/sites in the Company.
*The above is not an exhaustive list of duties; you may be required to fulfill other duties anywhere throughout the company as required.
- Quality Engineering
- Document control
- Quality control inspectors
- ISO 13485
- AS -9001
Experience and Knowledge:
- Postgraduate degree in a technical or regularity discipline desirable.
- 3rd level Qualification in Scientific/technical discipline.
- Ability to introduce and embed new systems successfully.
- Thorough understanding of ISO 13485.
- 10 + quality experience in manufacturing.
- Experience in subcontract manufacturing with numerous product lines.
- Experience in Quality management, including quality systems management.
- Experience leading and developing teams.
- Experience with FDA regulations desirable.
- Working conditions are normal for an office environment.
- In production areas employees are expected to follow all safety regulations, keep work area in a clean and orderly condition, and wear appropriate Personal Protective Equipment (PPE) as required for the assigned work area(s). Perform safety-related duties as assigned.