MST Compliance Support Specialist

Alvotech

Bengaluru

On-site

INR 1,100,000 - 2,100,000

Full time

5 days ago
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Job summary

Alvotech is seeking an MST Compliance Support Specialist in Bangalore to drive quality record and events management strategies across MST, including change controls and investigations. You will oversee CAPAs, deviations, and lab investigations with cross-functional QA support and ensure alignment with cGMP standards.

The role requires 5+ years of international quality/compliance experience in biopharmaceuticals, strong alliance management, and the ability to represent MST in senior review boards

Qualifications

  • Education: Bachelor’s/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.

Responsibilities

  • Establish MST Quality Record and Events management strategy, including change control and manufacturing investigations.
  • Oversight and tracking of Quality Events (change controls, CAPAs, deviations, lab investigations) across MST with timely follow-up based on criticality.
  • Standardization of Quality Record and Events management processes and harmonized approaches across MST teams.
  • Cross-functional collaboration to provide compliance support with external and internal QA partners.
  • Represent MST in review boards such as Product Quality Complaints, OOS/Deviation Review, and Control Strategy Review Boards.
  • Support quality audits and due diligence activities.
  • Quality review of MST documents and alignment with cGMP and internal requirements.
  • SOP and training material updates reflecting process changes and learnings.
  • Cross-site matrix management and oversight of MST outsourced activities.
  • Serve as the single point of contact for all MST compliance information and queries.
  • Perform additional duties beyond listed responsibilities as required.

Education

Bachelor's / Master's degree in a relevant discipline

Job description

## MST Compliance Support SpecialistApply: Bangalore Office: India Home Office: Full time: Posted 3 Days Ago: End Date: October 2, 2026 (7 days left to apply): JR100528**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.
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