About the role
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.
Originally posted on Himalayas