The posting
About the Job
Accountabilities:
- Overseeing daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans
- Maintaining his/her laboratory in compliance with the GMPs and quality control processes defined according to internal and external quality requirements and regulations
- Ensuring the use of validated methods in his/her perimeter and executing any validation/transfer protocol as receiving unit
- Managing and training laboratory staff, ensuring they follow best practices and safety guidelines
- Ensuring his/her laboratory staff is qualified to perform the testing execution by maintaining the lab qualification matrix
- Conducting routine shopfloor of laboratory to identify improvement opportunities
- Ensuring accurate and timely testing of received samples according to his/her perimeter
- Reviewing and approving laboratory test results and reports
- Maintaining laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities
- Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately
- Leading the quality control sample management process to support the adherence of the test’s execution to the committed standard times
- Ensuring the compliance of sampling and sample management with applicable regulatory requirements and company quality standards
- Handling sample management flows from sampling to receiving and dispatching to the appropriate labs (including stability and EM sample management per plan)
- Managing reference standards and reagents for the labs, in terms of stock, storage, validity to ensure test execution scheduling plans
- Managing retention samples storage throughout their lifecycle management, in compliance with regulatory requirements and company quality standards
- Ensuring the training management of quality control samplers or warehouse/manufacturing samplers when delegated
- Ensuring coordination of external/cross-site testing, including samples flows and results reports
- Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
- Providing support during regulatory inspections and audits by presenting stability program and records
- Representing the site in Microbiology areas, CoP led by global and, if requested, participating in the CoE and ensuring local communication (including also, if relevant for the site, being focal point for Business Operation -Hubs)
Additional accountabilities:
- Lead the microbiology section within QC to implement appropriate QC systems, from evaluation and selection of lab equipment to purchase. To lead and drive the equipment qualification activities, ensuring required consumables/reagents are purchased timely and the equipment installation and qualification activities are done as per projects milestones.
- Develop, improve, and maintain microbiological test methods. Identify opportunities, evaluate, initiate, monitor, and conclude operational excellence initiatives in the Microbiological test procedures and processes used at site.
- Write investigation reports for Initial Laboratory Investigation (ILI) for (OOT/OOS) and deviations, lead and oversee investigations related to all matters of testing related to microbiological topic not limited to product testing, environmental monitoring and water testing.
- Involve in Annual Product Quality Review Report (APQR) and preparation of environmental monitoring, and water testing trend result.
- Maintenance of specifications, lab methods, standard operating procedures and other GMP documents in the lab.
- Conduct training on Sampling, Microbiological testing to other personnel i.e. Chemical Technicians, lab analysts
- Ensure availability of workplace risk assessment and safe working procedures for contractor and the quality persom1el. Ensure safe working in all areas of work by practicing and communicating of safety message at +QDCI
- Other responsibilities that are not included in the above but are related to quality assignments.
About you
Education & Experience
- A degree in microbiology or any other related scientific discipline; with a minimum of 5 years hands-on experience in the laboratory and having been in supervisory roles for at least 2 years.
- Must be able to adopt hands-on troubleshooting style.
- Good knowledge of FDA regulations and cGMP is required. Good presentation skills and effective communication is required.
