QC Projects Assistant (12 Months Contract) Details Closing Date 2024/05/30 Reference Number NBI240517-1 Job Type Contract - Fixed Term Contract Job Title QC Projects Assistant (12 Months Contract) Department Quality Control Job Grade 8 Workplace Type On-site Location - Country South Africa Location - Province KwaZulu-Natal Location - Town / City Durban Minimum Education Level Diploma - Advanced Certificate Application Closing Date 30-May-2024 Job Category Pharmaceutical Job Advert Summary To ensure compliance with the NBI QC department’s projects plans and related cGMP requirements for QC projects and validation activities associated with QC projects. This includes co-ordinating and assisting with the drafting of required user requirement specifications (URSs) and validation protocols as well as co-ordinate the execution of commissioning activities and compilation of validation reports and standard operating procedures. Specific Operational Requirements The successful candidate will be required to work an 8-hour shift. May be required to work overtime to meet the business needs. Must be prepared to work shifts/weekends/public holidays when needed. Specific SHE Requirements Pre-employment, routine, and exit medicals are compulsory due to the nature of the business. Attendance to SHE-related training is mandatory. Adherence to SHE Instructions (Waste Segregation, Water and Energy Saving Initiatives) Compliance with SHE Site Rules is compulsory. NBI uses hazardous and biologically active chemicals. The successful candidate will be required to use proper PPE and will go through medical examinations as per OSH Act requirements. Matric with maths and scienceBachelor’s Degree or National Diploma in Chemical engineering, Biotechnology, Chemistry, Biochemistry, Pharmaceutical science or related science or Engineering field At least 6 months work experience in a laboratory preferably in a GMP environment Experience with good laboratory practices Method or equipment validation experience is an added advantage Project management experience, added advantage. Knowledge and understanding of cGMP. Experience of using software such as SAP and LIMS is an added advantageProject management qualification, added advantage. Duties&Responsibilities Co-ordinate the execution of the QC lab renovations and IPQC lab projects, including associated equipment Co-ordinate, assist and works with others to prepare relevant documentation for renovations and associated equipment, i.e. URS, validation protocols and reports. Works with others to co-ordinate the delivery of a project. Reports non-conformances, SHE issues, and breakdowns to senior team members Works with others to ensure project related SOP’s and logbooks are developed and implemented. Works with others to develop and document materials and people movement for assigned projects. Participates in validation studies as required. Works in a safe manner and ensures a safe working environment. Co-ordinate the commissioning activities Assists in co-ordinating the commissioning of the facility and the equipment. Works with others to draw up the validation protocols. Works with others to co-ordinate the equipment and processes qualifications for the IPQC laboratory, in consultation with the Validation Manager. Assists in co-ordinating the compilation of the validation reports. Assists to co-ordinate the implementation of the QC systems in the project related facilities and equipment. Procurement processes co-ordination Assists in executing the procurement processes for the assigned QC projects. Work with Procurement to address supplier queries to ensure on time delivery. Work with others including Engineering, Operations to co-ordinate the smooth execution of procurement tasks which are related to the project. Materials management Plan, organise, co-ordinate and monitor the stocks of materials required for the execution of projects related activities like commissioning in accordance with the project requirements (as specified in the QC project URS and validation protocol). Co-ordinate the ordering of stocks, preparation of reagents and appropriate storage according to correct recipes/procedures. Follow up with Procurement and Vendor to ensure delivery of required materials on time. Verify adherence to purchasing policy and related vendor documentation. Quality management Adhere to safety protocols and procedures. Co-ordinate the drafting of SOP’s for new equipment / methods and offer administrative support. Monitor maintenance and calibration programmes for assigned projects where support is required to achieve this compliance requirement. Ensure operational compliance by management of non-compliance through review of root cause analysis and implementation of required corrective action within agreed timeframes. Co-ordinate the calibration of instruments, always ensuring that calibrations schedules are adhered to. Ensures appropriate maintenance of records. Co-ordinate training and assessment of staff involved in the handover of a project at completion Administrative tasks Perform any required administrative tasks in keeping with the smooth running of the project File results and reports for easy retrieval. Submit and archive documents as per agreed Ensure appropriate maintenance of records. Communication and co-ordination Co-ordinate the liaison with suppliers in order to achieve projects and operational objectives. Co-ordinate and assist in communicating, following-up and sourcing information from external resources as required by the project. Liaise with suppliers and instrument engineers to resolve issues in a timely manner. Communicating with stakeholders to achieve deliverables and keep stakeholders informed of developments. Co-ordinate and assist to compile and submit reports timeously. Provide effective feedback on progress with assigned projects. Core Competencies Performance management Leading and influencing others Managing Relationships Business Impact Planning and organizing Follow-up Teamwork Attention to detail and analysis Quality orientation and awareness Technical/professional knowledge and proficiency Technical writing skills Good verbal and written communication skills #J-18808-Ljbffr