Keep the heartbeat of innovation running! Join our client in this Operations Manager position and ensure cutting-edge pharma operations never miss a beat!
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is seeking an Operations Manager to oversee quality control activities, including product and incoming goods testing as well as supporting microbiology and stability programs. In this role, you'll ensure that all materials, bulk, and finished products are tested in compliance with Good Manufacturing Practices (GMP) and the company's quality system. This position requires strong leadership, technical expertise, and a commitment to maintaining high-quality standards.
Responsibilities:
- Approve QC testing for bulk products, stability samples, and finished products in compliance with GMP.
- Approve or reject starting materials and packaging components as per GMP guidelines.
- Author, review, or approve documentation such as SOPs, laboratory batch protocols, methods, and reports.
- Ensure laboratory processes and equipment are governed by SOPs and maintained/calibrated as required.
- Lead investigations into out-of-specification (OOS) or out-of-trend (OOT) results, ensuring timely completion of corrective actions.
- Manage and support QC analysts and contractors, including performance reviews, training, and development.
- Oversee day-to-day QC activities and ensure alignment with production schedules.
- Coordinate third-party contractor testing and EU importation testing, resolving any issues or deviations.
- Support internal and external audits, inspections, and change control activities.
- Contribute to product quality reviews (PQRs), data collection, and continuous improvement initiatives.
- Escalate quality issues to the Head of Quality Control as needed.
Key Skills and Requirements:
- Strong knowledge of Quality Control, Quality Assurance, GMP, and regulatory compliance in pharmaceutical manufacturing.
- Ability to interpret complex data and present key findings effectively.
- Proficiency in computer applications such as Word, Excel, and PowerPoint.
- Demonstrated leadership and people management skills, with the ability to motivate and influence teams.
- Strong problem-solving, decision-making, and time management abilities.
- Excellent communication and presentation skills.
- Professional behavior, self-awareness, and a diplomatic approach to interactions.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
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