To assist the Quality Control Chemistry Team Leader in the shift management of the Quality Control laboratory in accordance to the company’s quality system and EU GMP.
To manage day-to-day functions of the team when required. To perform testing of finished goods according to specified approved procedures. To ensure established testing plan is executed and to provide assistance to team members when the need arises. To assign testing/ QC activities to QC personnel. To write and review standard operating procedures pertaining to QC activities. Reports and investigates LIRs and deviations in a timely manner. To assist outside contractors in performing calibrations throughout the company and keep records of these according to standard procedures as required. Ensures that general preparation of reagents, labelling, registration and associated documentation is carried out according to procedures. To routinely monitor and analyse the water supply according to Company procedures. To ensure that all equipment, apparatus and premises of the QC Department are functional and suitable for their intended use, by performing maintenance and calibration as instructed. Apparatus should be handled in the proper manner and not in a way which may be detrimental to its function. Ensures the use of certified reference substances (RS) and working standards (WS) according to procedure. To work out calculations pertaining to analysis and produce the relevant documentation in association always in compliance to EU GMP. To ensure proper filing and easy retrieval of all documentation and records pertaining to the QC Department. To support the Technical Services personnel on laboratory investigations resulting from OOS, OOT and OOE results and any deviations arising from the QC laboratory. To investigate and perform the prescribed hypothesis testing and analysis in conjunction with any quality and root cause analysis investigations. To assist the immediate superiors in problem solving exercises and other exercises aimed at improving quality and efficiency. To perform method validation as required. Input generated lab data in LIMS. To maintain records of stocks of reagents, equipment spares and reference standards in such a way as to report when re-ordering is due. To follow and document (record) precisely all activities as described in the relevant Standard Operating Procedures (SOPs), Test Methods and Protocols. To perform all duties as laid down and any additional duties as may be allocated from time to time by the QC Manager or delegate in a proper professional manner and in the best interest of APL Swift Services (Malta) Ltd. To perform troubleshooting on equipment, provide training and constantly improve processes within compliance to EU GMP.
If multiple Education and Language Profiles are defined, please note that you must fit at least one of them, but not necessarily all.
| Subject | Level | Grade |
|---|---|---|
| CHEMICAL | FIRST DEGREE / BACHELORATE | N.A. |
