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.
โ
If you are keen, please apply with your CV attached.
