A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
This position will be responsible for planning and managing, QA activities for contract manufacturing operations (CMOs) to meet compliance and business requirements and anticipate future needs. This position will also work directly with internal and external stakeholders to provide sustaining quality and compliance and routine support related to current commercialized products. Ensures that performance and quality of products conform to established standards and regulatory guidelines to ensure patient safety. This position requires both domestic and international travel up to 30% of time.
- Manage deviations, investigations, CAPA measures, change control, ERP Master Data and Artwork Management
- Generate and maintain Product Quality Reviews
- Prepare monthly CMO quality metrics for management oversight review
- Participates in and provides support to cross-functional teams in relation to product investigation, regulatory audits/inquires, implementation of new/revised GxP guidelines and improvement initiatives
- Implements appropriate standards and practices for quality of contract manufacturing operations and ensures alignment with industry best practices
- Generate and maintain Quality Technical Agreements (QTAs)
- Ensures alignment with PQS for implementation of GxP activities with a focus on external GMP manufacturing and GDP for commercial products.
- Manages quality risk assessment process for CMOs and efforts to execute risk mitigation plans
- Provide QA support for interdepartmental project work
- Reviewing and preparing the batch documentation for the market release by the Qualified Person as applicable including clarifying questions with the CMO partners.
Candidates Profile :
- Required Qualification : Graduate / Post Graduate in Pharmacy or Science
- Job Specific Competencies & Skills : Able to successfully influence others within project teams regarding quality or compliance concerns. Broad insight of bio & pharmaceutical manufacturing. Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment. Excellent verbal & written communication skills in English.
- Work Experience Required :
- Minimum 5 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences required
- Demonstrated ability to work across matrix organization in international and multi-cultural environment
- Experience in working with external partners (e.g. contract manufacturing organizations, contract laboratories and suppliers) is preferred
- Good understanding of external compliance trends and ability to address needs based on external demand
- Strong knowledge of technical writing and project management skills,
- Excellent organization and presentation skills
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com