Deskripsi Pekerjaan
Are you a seasoned quality assurance professional with a passion for operational excellence within the pharmaceutical industry? PERSOL is seeking a Senior Operations & QA Specialist to join our dynamic team in the West Region. In this pivotal role, you will act as a guardian of product integrity, ensuring that all manufacturing and operational processes adhere strictly to global regulatory standards.
You will be responsible for bridging the gap between operational efficiency and stringent quality compliance. The ideal candidate will thrive in a fast-paced environment, possess a meticulous eye for detail, and have the leadership skills to mentor junior staff while driving continuous improvement initiatives. If you are committed to delivering excellence in healthcare solutions and wish to elevate your career within a globally recognized firm, we want to hear from you.
Tanggung Jawab
- Oversee end-to-end quality assurance processes to ensure compliance with cGMP and local regulatory requirements.
- Monitor production workflows to identify bottlenecks and implement corrective and preventive actions (CAPA).
- Conduct regular internal audits and prepare comprehensive reports for management and external regulatory bodies.
- Manage documentation control and ensure all Standard Operating Procedures (SOPs) are up-to-date and compliant.
- Collaborate with cross-functional teams, including supply chain and production, to streamline operational efficiency.
- Provide technical guidance and QA training to operational staff to maintain high standards of product quality.
- Handle product quality investigations and lead root cause analysis for any non-conformance issues.
Kualifikasi
- Bachelor’s Degree in Pharmacy, Chemistry, Life Sciences, or a related engineering field.
- Minimum 5-7 years of experience in QA/Operations within a pharmaceutical or medical device manufacturing environment.
- Deep understanding of FDA, HSA, or EU GMP regulatory frameworks.
- Proven ability to manage documentation systems and quality management systems (QMS).
- Strong analytical skills with proficiency in data-driven decision-making and CAPA management.
- Excellent communication skills with the ability to liaise with stakeholders at all organizational levels.
- Professional certification in Quality Management (e.g., Six Sigma, ASQ) is highly advantageous.