Shelcel Biozeen Technologies

Role & responsibilities Position Overview: We are seeking a highly skilled and experienced Senior Engineer in Quality Assurance to join our dynamic team at BiOZEEN. The successful candidate will play a key role in ensuring the highest standards of quality, compliance, and efficiency in our biopharmaceutical equipment qualification used for vaccine manufacturing processes. Job Description: 1) We are looking for an efficient, skilled, creative and experienced Senior Engineer - Quality Assurance to join BiOZEEN. 2) The successful candidate will work closely with the Dy. Manager Quality Assurance to ensure that our products meet quality and regulatory requirements. This includes overseeing and review of the Qualification of equipment as per testing protocol and procedures. 3) The successful candidate must have the temperament and reporting skills for conducting audits and investigations to ensure compliance to standards and guidelines. Key Responsibilities: 1) Compliance Management: Ensure compliance with relevant standards and guidelines, including FDA regulations, ISO standards, and cGMP guidelines, ASME, CE, WHO, US FDA CFR, GAMP and other regulatory bodies. Participate in internal and external audits, addressing findings and implementing corrective actions. 2) Quality Testing & Equipment Qualification: Develop, implement, and maintain robust Equipment Qualification (DQ, IQ & OQ) for bioprocess equipment, systems, and manufacturing processes. Competent to perform/write: Design Qualification Installation Qualification (IQ) & Operational Qualification (OQ) of Equipment Risk Analysis and HAZOP Others as per Project Requirement. Review of Manufacturing Documents, Component Literature/specifications and Testing documents, including batch records, SOPs etc. Execution of Pre-FAT, FAT & SAT. 3) Process Improvement: Ability to perform analyses to identify areas for improvement. Identify opportunities for optimization in testing/qualification and cost reduction while maintaining high-quality standards. Collaborate with cross-functional teams to implement continual improvements at BiO ZEEN. 4) Risk Management: Perform risk assessment activities, ensuring proactive identification and mitigation of risks related to product quality, safety, and regulatory compliance. 5) Customer Satisfaction: Collaborate with stakeholders to understand customer feedback and ensure CAPA Effectiveness to enhance customer satisfaction. 6) Training and Development: Provide training and mentorship to junior QA engineers and other relevant personnel. Stay updated on industry trends and share knowledge within the team. Qualifications and Requirements: 1) Bachelors or master’s degree in a relevant field such as Biotechnology, Biology, Chemistry, or Mechanical Engineering. 2) At least 4 years of experience in Quality Assurance in a biotechnology manufacturing environment. 3) Experience with regulatory compliance, including FDA regulations, ISO standards, and cGMP guidelines. 4) Strong knowledge of Quality Systems and procedures, including auditing, investigations, and CAPA/CARA. 5) Excellent communication and interpersonal skills, with the ability to work effectively in a team environment. 6) Proficient with creating and submitting status reports and QA Dept. objective matrices. 7) Strong analytical and problem-solving skills, with the ability to manage multiple projects simultaneously. 8) Proficiency in Microsoft Office, including Word, Excel, and PowerPoint. Preferred candidate profile