QA Review/Release Lead, QP
Reporting to the Head of Quality Assurance, this role will play an important role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility and accountability of the site Quality Review and Release. Working closely with senior leaders in all areas of the business, this position will ensure high quality product is released by WuXi Wuppertal site. The individual will support in ensuring GMP quality system is maintained adhering to all regulatory, cGMP and company requirements.
- Act as site QP with responsibility of overseeing local GMP manufacturing protocol, release of manufactured drug substance to client per QAA or release finished product to EU market per EU regulation as needed.
- Release of raw material, IPC, equipment, rooms, utility, facility, etc.
- Accountable for certifications, e.g., Certificates of Conformity, Analysis, and other certificates as appropriate
- Accountable for handling of complaints, recalls.
- Accountable for communication with client QA as needed to support release of bulk drug substance.
- Accountable to review and approve manufacturing and QC generated documents, include but not limited to batch records, SOPs, QRM, test records, forms, logbooks, and labels etc.
- Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective, include but not limited to deviation, CAPA, change control, qualification.
- This role will support for the preparation of regulatory submissions and inspection readiness.
- This role also will be responsible for setting up and manage a high-class QA Review/Release team, including planning, recruiting/hiring.
- Responsibility for the relevant coaching/mentoring and training being provided to employees who carry out QA Review/Release duties to ensure site SOPs are followed, accurate identification of deviations or any other quality issues