My client is a global company focusing on R&D of pharmaceutical ingredients, drug formulations and healthcare related products.
They are currently looking for a Quality Control Assistant Manager to manage the Quality Control Laboratory.
Responsibilities:
- Coordinating department activities to meet schedules and targets.
- Enhancing and maintaining the laboratory's quality system.
- Improving the laboratory to meet customer and regulatory requirements.
- Ensuring the establishment of robust systems for sampling, analytical testing, and stability testing procedures and protocols.
- Ensuring the implementation of effective systems for recording and storing analytical data.
- Managing electronic data security and storage.
- Establishing and maintaining systems for the qualification, maintenance, calibration, and checking of analytical instruments, including operational software.
- Overseeing the release/rejection of raw materials, packaging materials, and in-house produced materials.
- Investigating and resolving Out of Specification (OOS), Out of Trend (OOT), and Exception Not Resolved (ENR) issues.
- Overseeing the transfer, verification, and validation of analytical methods.
- Preparing, facilitating, and serving as a Subject Matter Expert (SME) for customer audits and regulatory audits.
Qualifications:
- Bachelor's or Master's degree in a relevant field (e.g., Chemistry, Pharmacy, Quality Assurance).
- Strong knowledge of GMP (Good Manufacturing Practices), ICH guidelines, and other relevant quality standards and regulations.
- Excellent communication and interpersonal skills.
- Strong problem-solving and decision-making abilities.
- Attention to detail and a commitment to maintaining high-quality standards.
- Experience with quality management software and tools.
If you are keen, please apply with your CV attached.
