Senior Quality Manager
hace 2 semanas
Job Title: Senior Quality Manager - Process Validation and Tech Transfer
About the Role:
We are seeking a highly experienced Senior Quality Manager to join our team. In this role, you will be responsible for providing quality oversight and support to Validation and Tech Transfer manufacturing operations within our company or at contracted suppliers.
Main Responsibilities:
- Participate in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to Validation and Tech Transfer manufacturing operations.
- Contribute to the Validation strategy for new products and second sources to ensure compliance to regulations and risk mitigation strategies.
- Conduct Validation and Tech Transfer GMP document reviews including Master Validation Plans, Protocols, and Reports.
- Assist Change Control owners with ensuring compliance to change procedure requirements, assess and approve change controls.
- Conduct quality investigations/deviations and reviews corrective action plans for adequacy and compliance.
Requirements:
- Experience providing Quality support and oversight of GMP manufacturing operations for validations and tech transfers.
- Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.
- In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing.
- Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
Apply Now:
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