Senior Associate - Quality Assurance (MES)
Company Overview: We are a global healthcare organization committed to enhancing the quality of life through the development and delivery of innovative medicines. Our mission is to improve health outcomes worldwide by pioneering new biopharmaceutical solutions.
About Us: Our organization is dedicated to advancing the healthcare industry through cutting-edge biotechnology. We operate state-of-the-art manufacturing facilities focused on producing next-generation biopharmaceuticals.
Position Summary: As a Senior Associate in Quality Assurance specializing in Manufacturing Execution Systems (MES), you will play a pivotal role in ensuring the quality and regulatory compliance of biopharmaceutical products within our advanced manufacturing environment. You will collaborate closely with cross-functional teams to implement and uphold rigorous quality assurance standards, facilitate inspections and audits, and drive continuous improvement initiatives.
Key Responsibilities:
1. Quality Assurance Oversight for MES:
o Develop and maintain quality assurance procedures, policies, and systems.
o Conduct routine self-inspections and monitoring assessments to ensure compliance with regulatory requirements such as cGMP (current Good Manufacturing Practices).
o Work collaboratively with automation, IT, and production teams to uphold quality standards throughout the manufacturing process.
o Investigate and address deviations, non-conformities, and implement Corrective and Preventive Actions (CAPA) related to MES quality events.
o Participate in cross-functional teams to ensure consistency across all manufacturing execution systems.
2. Regulatory Compliance:
o Stay abreast of industry regulations, guidelines, and best practices.
o Assist in preparing for and participating in regulatory inspections and audits.
o Ensure adherence to processes including periodic review, change control, deviation management, and security measures for MES.
3. Documentation and Reporting:
o Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
o Develop local procedures specific to MES and support the review and approval of GMP (Good Manufacturing Practice) documents related to MES qualification and validation.
4. Quality Improvement Initiatives:
o Identify opportunities for process improvement and collaborate with cross-functional teams to implement enhancements.
o Participate in risk assessments and contribute to quality improvement projects.
5. Training and Development:
o Communicate GMP requirements and regulatory updates related to MES to personnel.
o Stay informed about advancements in electronic batch records (eBRs) and best practices in quality assurance.
Basic Qualifications:
• Bachelor’s (BSc, Hons BSc) or advanced degree (MSc, PhD) in Science, Engineering, Quality, or a related discipline.
• Minimum of 3 years of experience in quality assurance within biotechnology, pharmaceuticals, or medical device manufacturing.
Additional Qualifications:
• Proficiency in cGMP, FDA regulations, Data Integrity, Quality Risk Management, and other relevant biopharmaceutical regulatory requirements.
• Strong problem-solving and analytical skills.
• Detail-oriented with a strong commitment to maintaining high-quality standards.
• Effective communication and teamwork skills.
• Proven initiative and ability to work independently with a continuous improvement mindset.
• Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is advantageous.
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