Position Summary
Responsibilities
Provide expert guidance on GMP compliance and quality assurance best practices.
Lead internal audits, including planning, conducting, reporting, and following up on audit findings.
Oversee management of non-conformities, corrective and preventive actions (CAPA), change controls, and complaint handling.
Review and approve equipment qualification (IQ, OQ, PQ) and validation activities to ensure compliance with regulatory and company standards.
Ensure the QMS is effectively maintained, updated, and communicated across all relevant departments.
Develop and deliver training programs to staff on quality policies, procedures, and regulatory requirements.
Collaborate closely with spaneting and sales teams to prepare for and support client audits and meet customer requirements.
Maintain comprehensive and accurate documentation related to quality activities, equipment qualification, and validation.
Participate in continuous improvement initiatives to enhance quality and compliance.
Qualifications
Provide expert guidance on GMP compliance
Lead internal including preparation, execution, and follow-up on findings
Oversee non-conformities, CAPAs, change controls, and complaint management processes.
Ensure the QMS is effectively maintained, updated, and communicated across departments.
Train and mentor staff on quality policies, procedures, and regulatory expectations.
Collaborate with spaneting and sales team to support client audit and requirement
Preferred certificate as a quality auditor (e.g. ISO9001)
Experience with EQMS
Bachelor’s degree in Chemistry, Biotechnology, or related field
Minimum 10 years of experience QA roles within GMP-regulated pharmaceutical or biopharmaceutical industries.