The QA Compliance Officer is responsible for ensuring adherence to current and pending EU GMP and US FDA requirements, maintaining compliance with regulatory standards, and supporting quality assurance activities.
This role requires excellent verbal and written communication skills and the ability to work collaboratively within a team environment.
LocationOnsite As a QA Compliance Officer, you will be responsible forConducting routine quality audits of the facility to ensure compliance and proactively resolving arising issues.
Establishing and maintaining the internal audit schedule, ensuring its completion as planned.
Preparing and conducting the annual GMP training program for the site.
Approving compliance documents such as Deviations, SCARs, and CAPAs.
Conducting external audits, compiling audit reports, and leading response collation.
Managing and assisting with the site change control system.
Handling customer complaints efficiently.
Providing technical support to the MAH for new product introductions and existing products.
Reviewing and leading process investigations, ensuring appropriate documentation and corrective actions where necessary.
Ensuring process transfers are documented and conducted in accordance with regulatory standards.
Conducting quality reviews and approving RMWOs & RPWOs for Chanelle.
Updating quality procedures in response to validation issues in cooperation with relevant departments.
Contributing to the continuous improvement of the company's quality system and GMP compliance.
Maintaining records for company KPIs in line with quality management review requirements.
Providing timely feedback on customer and production queries.
Preparing product quality review reports for Chanelle.
Assisting in troubleshooting product-related issues.
Performing finished goods inspections for all manufactured and packaged products before release and shipment.
Conducting GMP walks as required.
Assisting with QA review and approval of executed Manufacturing, Filling, and Packaging Work Orders in preparation for QP release.
Preparing Certificates of Analysis for QP release.
Undertaking any other duties assigned by the QA Manager or Head of Quality.
Qualifications & ExperienceBachelor's degree in a science-based discipline.
Minimum of 1–3 years' experience in a pharmaceutical manufacturing environment.
Working knowledge of EU GMP and US FDA guidelines.
Skills & CompetenciesAbility to take direction and ask questions as needed.
Strong teamwork and collaboration skills.
Proactive development of technical skills.
Methodical, systematic, and structured approach to organizing work.
Ability to prioritize decision-making, differentiating between urgent and non-urgent matters.
Ability to escalate issues appropriately.
Willingness to help others and contribute to a positive team environment.
Displays flexibility and a willingness to learn and go the extra mile.