Job Title: QA Specialist
Quality Assurance is a critical function within the Pharmaceutical industry, ensuring that products are safe and effective for consumers.
Key Responsibilities:
* Complete auditing/review of batch documentation to ensure compliance with SOPs, GMPs and applicable regulations.
* Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
* Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
* Utilize this network to help resolve comments and issues that arise during audit and review.
* Manage product recalls and stock recoveries as appropriate.
* Identify compliance gaps and make recommendations for continuous improvement.
* Create and maintain assigned SOPs.
* Perform and review complaints and deviation investigations, change controls and CAPA's.
* Assist in the induction process for new starters and training of other staff.
* Generally follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
* Compile data for reports and presentations, provide data interpretation, draw conclusions.
* Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
* Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
* Represents department on cross-functional teams.
* Assist in the generation, review and approval of Technical & Quality Agreements.
Requirements:
The ideal candidate will have a Bachelor degree in a Quality, Science or Engineering discipline, potentially with a higher degree and/or significant industrial experience. A minimum of 3 years relevant post-degree experience in a GMP environment is required.
Benefits:
This is an excellent opportunity to join a leading multinational organization in the Pharmaceutical industry. As a member of our team, you will be part of a dynamic and growing company that values its employees and invests in their growth and development.
Why Join Us?
By joining our team, you will have the opportunity to work with a talented and dedicated group of professionals who are passionate about delivering high-quality products and services. You will also have access to ongoing training and development opportunities to help you achieve your career goals.