MST Compliance Support Specialist

Key responsibilities and minimum requirements according to job level:
High level of independence and accountability for large projects and development within field.
Performs variety of tasks of variable complexity.
Takes part in large strategic projects.
Challenges and decisions faced in the role are often non-precedent.
Can have impact on large, important projects.
Leading expert within field – guides and coaches' other employees.
Competencies required to fulfill the employee responsibilities and work assignments:
An employee shall follow the job description that pertains to his/her position. In addition, an employee shall follow the SOPs that pertains to his/her position.
An employee shall adhere to the company policies and procedures that are available on the Alvotech intranet – Alvocado.
The MST Compliance support specialist shall be responsible for:
Establish MST Quality Record and Events (change control, manufacturing investigation etc.) management strategy, including specification and internal and external manufacturing related change controls
Oversight and tracking of Quality Events (change controls, change actions, CAPA's, deviations, lab investigations) across MST, ensuring timely follow-up based on criticality and priority.
Standardization of Quality Record and Events management processes- establishment and stanrdadization of the relevant processes and procedures and ensuring harmonized approach across the MST teams
Cross Functional Collaboration - serve an alliance for compliance queries/issues with external and operational QA
Represent MST in relevant review boards, e.g. Product Quality Complaints Review Board, OOS and Deviation Review Board, Control Strategy Review Board etc.
Support in quality audits and due diligence activities
Quality review of MST documents- Review MST reports against the relevant source documents and ensure alignment with cGMP strandards and internal compliance requirements
SOP & Training Material Updates: Contribute to the revision and development of SOPs, training materials, and controlled documents based on process changes and campaign learnings.
Cross-site matrix management and compliance overview of MST outsourced activities
Serving as the one point of contact for all compliance related information and queries within MST
Performing activities above and beyond their responsibilities as and when required
Minimum education and experience required for the role
Education: Bachelors/Master’s degree in a relevant discipline and direct industry experience or extensive experience in the pharmaceutical or biopharmaceutical sector.
Experience: Greater than 5 years international experience in Quality and/or Compliance Management in Biopharmaceutical or related industries. Demonstrated scientific and alliance management skills.