
Senior Quality Assurance Lead
5 days ago
A Quality Compliance Manager will play a pivotal role in ensuring operational excellence and inspection readiness.
- Provide quality oversight and support for operations in manufacturing, testing, packaging, and material management, ensuring compliance with regulatory procedures.
- Offer expert guidance for GMP product quality assurance and compliance in manufacturing operations, laboratory operations, and warehousing activities.
- Review batch records, cleaning records, SOPs, EOPs, change requests, protocols, reports, etc., to ensure adherence to site procedures.
- Collaborate as a quality business partner for process transfer and validation activities, partnering with cross-functional teams to ensure successful transfer and validation of processes.
- Provide quality oversight and support for operations, offer expert guidance, review batch and cleaning records, and collaborate as a quality business partner.
- Support internal inspection readiness, drive continuous improvement initiatives through Lean methodology, and instill a strong quality and compliance culture across the site.
- Bachelor's degree in pharmaceutical, biological, or chemical sciences; relevant advanced degree preferred.
- 5+ years of relevant experience in Pharmaceutical and/or Animal Health industry, with current knowledge of cGMPs required.
- Significant experience in equipment commissioning/qualification, cleaning validation, and process validation desirable.
- Demonstrated knowledge and success in working with cross-functional teams.
- Ability to develop and adhere to self-directed standard work, organized and methodical, with ability to take initiative with minimal guidance.
- Strong written and oral communication skills, collaboration, leadership, and influencing skills.
- Results-driven professional with passion to win and demonstrated record in achieving goals.
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