Bachelor's/Master's in Life Sciences, Pharmacy, or related field
3-5 years of experience in QA/project management in pharma/biotech
Familiarity with GMP regulations and project management methodologies
Strong communication skills, capable of effective stakeholder engagement
Proficiency in project management tools (Jira, Aspera, MS Project) and document control systems (SharePoint, Document Vault)
Responsibilities
Oversee QA projects to ensure they align with quality and timeliness standards
Coordinate with cross-functional teams across QC, Regulatory, and other departments
Develop and implement project plans and timelines to track progress
Ensure adherence to GMP and other regulatory requirements
Identify potential project risks and develop mitigation strategies
Collaborate with stakeholders to manage project scope and changes
Support audits and other quality-related activities as needed
Benefits
Flexible working hours
Opportunity for career development within the organization
Work in a collaborative and supportive team environment
Access to ongoing training and professional development programs
Participation in company-sponsored health initiatives
Full Job Description
Job Title: Senior QA Specialist I Reports to: Quality Assurance Manager/ Specialist II Location: US-CRAN
Job Summary: We're seeking an experienced QA Specialist to join our Quality Assurance team. The successful candidate will be responsible for leading QA projects, ensuring quality and timely delivery. Coordinate cross-functional teams, manage timelines, and ensure GMP compliance. Drive project success through effective communication and risk management.
Key Responsibilities:
- Oversee QA projects, ensuring timely completion and quality - Coordinate cross-functional teams (QC, Regulatory and other relevant departments etc.) - Develop and execute project plans, timelines - Ensure compliance with GMP, regulatory requirements - Identify and mitigate project risks, track progress - Collaborate with stakeholders on project scope, changes
Support audits and other activities as required.
Requirements:
-Bachelor's/Master's in relevant field (e.g., Life Sciences, Pharmacy) - 3-5 years in QA/project management, preferably in pharma/biotech -GMP regulations, project management methodologies -Strong communication, problem-solving, and organizational skills and Tools such as Project management: Jira, Aspera, MS Project, Document control: SharePoint, Document Vault ( any skill would be a plus)
