Senior Quality Assurance Specialist
2 months ago
We are seeking a highly motivated and experienced Senior Quality Assurance Specialist to join our team at Lonza. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products and processes.
Key Responsibilities- Monitor and maintain quality assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility.
- Review and approve SOPs, protocols, reports, and records to ensure compliance with regulatory requirements.
- Participate in regulatory inspections and customer audits as required.
- Identify and implement process improvements to enhance quality and efficiency.
- Collaborate with cross-functional teams to ensure effective communication and coordination.
- Provide training and guidance to new members and manufacturing staff on quality procedures and protocols.
- Review and approve quality-related documents, including batch records and logbooks.
- Compile and review lot genealogy and disposition packages to ensure timely release of product.
- Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA.
- Escalate quality events on the floor based on knowledge of defined SOPs and policies.
- Support changeover activities and QA on Call.
- Degree in science or related field.
- Relevant work experience in Pharmaceutical Manufacturing industry or Validation / Quality unit in the Biopharmaceutical industry.
- Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
- Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility.
- Team player who can operate independently, with strong focus on safety, quality, and timelines.
Lonza is a global leader in life sciences operating across three continents. We are committed to improving lives through innovative solutions and products. Our people are our greatest asset, and we offer a dynamic and challenging work environment that fosters growth and development.
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