02 Oct
|
Alvotech
|
India
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, significant 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
📌 MST Compliance Support Specialist (India)
🏢 Alvotech
📍 India