We are looking for a detail-oriented and experienced Senior Quality Assurance Officer (Quality Management Systems & EOHS) to support the maintenance and continuous improvement of our Quality Management System (QMS) and Environment, Occupational Health & Safety (EOHS) Management System, ensuring continued compliance with applicable regulatory and company requirements.
The role reports directly to the Quality Management Systems Manager.
Key Responsibilities:
- Prepare, update and maintain SOPs/SOFs in accordance with company policies, EU cGMP requirements and applicable EOHS requirements.
- Support the preparation for regulatory and client audits and participate in the company's self-inspection programme.
- Maintain QA documentation, quality logs, document registers and associated records to ensure continued compliance.
- Assist in the investigation, follow-up and closure of deviations.
- Collaborate cross-functionally with internal departments to ensure that quality, regulatory and EOHS requirements are effectively integrated into company processes.
- Assist in the implementation and maintenance of the company's training programme and ensure that required employee training is appropriately managed and documented.
- Manage the Supplier Qualification Programme.
- Review Corrective and Preventive Actions (CAPAs), monitor their implementation and effectiveness, and support the overall CAPA Programme as part of continuous improvement.
- Support the external audit programme.
- Assist in the registration, follow-up, risk assessment and closure of change controls.
- Assist in the review of asset calibration and/or qualification documentation.
- Maintain and support the company's EOHS Management System, ensuring that relevant procedures, records and programmes remain current and effectively implemented.
- Coordinate and follow up on EOHS risk assessments, inspections, incidents, near misses and associated corrective/preventive actions.
- Support the implementation and monitoring of occupational health and safety, environmental, emergency preparedness and workplace safety programmes.
- Maintain applicable EOHS documentation, registers, records and training requirements and support compliance with applicable legislation and company standards.
- Participate in EOHS audits, inspections and continuous improvement initiatives, following up on identified actions through to closure.
Requirements:
- Bachelor's degree or higher in Pharmacy, Life Sciences, or a related discipline.
- Minimum of 4 years' experience in Quality Management within the pharmaceutical industry.
- Sound knowledge of EU cGMP and applicable local regulatory requirements.
- Knowledge or experience in Environment, Occupational Health & Safety (EOHS) systems would be considered an asset.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
- Strong organisational and problem-solving skills, with a high level of attention to detail.
- Ability to manage multiple priorities and follow actions through to completion.
- Must be in a possession of a valid work permit
What We Offer:
- Competitive remuneration package.
- Comprehensive health insurance.
- Continuous professional growth and development opportunities.
- The opportunity to work in a state-of-the-art Testing and Batch Certification Facility within a dynamic pharmaceutical quality environment.