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Senior QA Systems Specialist
Audit, GMP, Compliance, Training System Management, Inspection Readiness
Job
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.For our client Johnson & Johnson MedTech - Vision we are searching for a Senior QA Systems Specialist .
Keywords
- External Audit Coordination
- GMP Compliance
- Training System Management
- Inspection Readiness
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A core part of your role is serving as the primary co-ordinator for external audits conducted by regulatory authorities, notified bodies, and customers. You plan and manage audit activities across departments, act as the main point of contact for auditors, and ensure timely preparation of materials including SME involvement, documentation, and facility readiness. You lead audit response activities, co-ordinate responses to observations, and oversee the tracking and closure of CAPAs.
As owner of the site GxP Training System, you ensure all employees are trained and qualified in line with internal procedures and regulatory requirements. You oversee curricula development and maintenance, role-based training assignments, and training effectiveness evaluations. Training records are maintained in compliance with data integrity standards, supported by a Training Technician. You also lead digitalisation and improvement initiatives related to the training system.
Beyond audits and training, you support and maintain QA systems aligned with GMP, ISO, and regulatory requirements, ensure procedures remain up to date, and participate in internal audits. You monitor regulatory updates, implement necessary changes, and provide guidance to departments on compliance expectations.
Profile
You hold a Bachelor's or Master's degree in Life Sciences, Engineering, or a related field, and bring at least 5 years of experience in Quality Assurance within a regulated manufacturing environment such as pharmaceutical or medical device. You have a proven track record in managing external audits and inspections, as well as hands-on experience with training system ownership.Other qualities are:
- In-depth knowledge of GMP, ISO standards, and applicable regulatory requirements;
- Strong organisational and project management skills;
- Excellent communication and stake holder management abilities;
- Detail-oriented with a proactive, problem-solving mindset.
Benefits
Onsite project for at least 6 monthsCompany profile
Johnson & Johnson Vision combines science, technology, and people to help preserve and restore sight world-wide. Partnering with eye care professionals, the organisation delivers a broad portfolio of solutions including ACUVUE® contact lenses, consumer eye health products, dry eye treatments, and refractive and cataract solutions. Working at Johnson & Johnson Vision means contributing to meaningful healthcare innovation as part of a global organisation driven by purpose and impact.
