QA Compliance Officer
To assist in the process of maintaining compliance to Product Licences/ Marketing authorisations for Realoch Pharma
- Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may
- Set up and maintain the Internal Audit schedule and ensure its completion as per
- Prepare and conduct annual GMP training programme for the
- Approval of Compliance documents e.g. Deviations, SCARS and CAP
- Conduct External audits and compile External Audit reports and lead the collation of resp
- Management and assistance with the site change control
- Handling of customer
- Provide technical support to the MAH for New Product Introductions and existing Products.
- Review/lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
- Ensure Process transfer is documented and conducted in accordance with Regulatory Standards.
- Quality review and approval of RMWO’s & RPWO’s for Realoch
- Provision/Updating of existing Quality Procedures in line with issues as they arise as result of validation in cooperation with the appropriate department.
- Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality
- Maintenance of records for the company KPls as per Quality management review requirements.
- Ensure timely feedback on customer/production queries as appropriate.
- Preparing product quality review reports for Realoch Pharma.
- Assist in trouble-shooting product problems.
Any other duties assigned by the Head of Quality
- Degree in Science discipline or equivalent.
- Minimum of 3 years Quality Assurance experience within the pharmaceutical industry B.Sc. degree as a minimum requirement.
- Strong organisational skills / ability to prioritize work
- Proven track record as a team player.
- Excellent communication and presentation skills with a hands-on approach