Key Responsibilities:
1.Quality Oversight:
oEnsure all manufacturing processes, including aseptic filling, lyophilization, visual inspection, and packaging, comply with cGMP, FDA, EMA, and other relevant regulatory guidelines.
oImplement and maintain quality systems to ensure product quality and regulatory compliance.
ooversee aseptic processing and sterility assurance programs, including environmental monitoring, media fill simulations, and validation activities.
oEnsure all processes and documentation meet regulatory requirements and company standards.
oAs key player to support client and regulatory inspections. Ensure timely and effective resolution of audit findings.
oDeep involve in the process of deviation, change control and complaints in the DP area.
2.Team Leadership and People Development:
oLead and manage DP QA team, providing guidance, training, and performance evaluations.
oDevelop and implement training programs to enhance the skills and knowledge of the QA team, ensuring they are well-equipped to meet regulatory standards.
oFoster a culture of continuous improvement and professional development.
oIdentify and nurture high-potential employees, providing them with opportunities for growth and advancement within the organization.
3.Cross-Functional Collaboration:
oWork closely with Production, Engineering, MSAT, and other departments to ensure seamless integration of quality processes.
oProvide input and support for process improvements and new product introductions.
Qualifications:
oBachelor’s degree or above in a relevant field (e.g., Biology, Chemistry, Pharmacy, Engineering) or equivalent experience.
o8 years of experience in a QA, production or MSAT role within the biopharmaceutical industry. And 3 years in management role
oProven experience and knowledge in aseptic processing, sterility assurance, and environmental monitoring.
oStrong leadership and team management skills.
oDecision-making and critical thinking abilities.
oAbility to work effectively in a fast-paced, dynamic environment.