MST Compliance Support Specialist
Alvotech · Bengaluru
- Experience5–6 yrs
- SalaryNot disclosed
- Work modeonsite
- Levelsenior
- Posted21 Sept 2026
About Alvotech
Alvotech is hiring in Bengaluru in pharma biotech. This role looks for around 5+ years of experience.
Skills
- Quality compliance management
- Quality events management
- Change control
- CAPA
- Deviation management
- cGMP
- Quality audits
- SOP development
- Biopharmaceutical industry
The role
A regulatory compliance specialist at a biopharmaceutical company manages quality events, cGMP compliance, and change controls across manufacturing teams and external partners. The role reviews quality records, supports audits, and standardizes compliance processes.
Full job description
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 controlsOversight 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 teamsCross Functional Collaboration - serve an alliance for compliance queries/issues with external and operational QARepresent 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 activitiesQuality review of MST documents- Review MST reports against the relevant source documents and ensure alignment with cGMP strandards and internal compliance requirementsSOP & 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 activitiesServing as the one point of contact for all compliance related information and queries within MSTPerforming 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.