QC Analyst Night Shift 33 views

Purpose:

A manufacturer that specialises in pharmaceutical products made from human plasma is seeking a QC Analyst Night Shift who will be responsible to ensure quality, safety and efficacy of products through quality control processes applying the principles of good laboratory practice and good manufacturing practice

Key Job Outputs:

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
• The company 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

Perform testing of starting, intermediate and final products and other samples

• Plan, organise and co-ordinate verification and testing of incoming samples in accordance with the product specifications, production requirements and/or dossier requirements (as specified in the QC program)
• Prepare reagents/buffers according to correct recipes/procedures
• Perform process sampling or process verification where required to fulfil testing requirements
• Perform analytical tests according to the approved SOP’s
• Ensure accuracy and validity of the results by checking controls and using approved statistical methods
• Record test results in the relevant protocol and report within set timelines
• Process results in LIMS and/or SAP and monitor trends periodically as per schedule
• Be multi-skilled in all aspects of laboratory testing
• Track and monitor the progress of testing and reporting of samples
• Participate in international collaborative studies with national and internationally recognised bodies
• Preparation of in-house controls and standards
• Provide technical expertise to internal customers
• Perform out-of-spec investigations and handling of product quality related complaints

Laboratory maintenance

• Perform routine maintenance of lab equipment (in-house or via external contractors)
• Perform routine general laboratory maintenance
• Ensure the lab is clean and tidy at all times
• Monitor the lab as per schedule
• Clean glassware immediately after use
• Monitor departmental stock usage and wastage of test kits and reagents and laboratory consumables and take necessary action to enhance cost effectiveness

Method development and validation and equipment qualification

• Perform test and method validations according to internal QC program and perform validations on new equipment
• Draw up user requirement specifications
• Prepare validation/qualification protocols
• Perform validations and equipment qualifications
• Prepare validation report/s
• Implement method/ equipment
• Develop/optimise methods for approval by QC manager
• Monitor performance of assigned method/s and instruments

Raw material testing

• Perform sampling, testing and reporting of raw materials such as chemicals, media, water, printed and packaging components by
• Following the appropriate procedures/practise
• Receiving and retaining samples in the appropriate containers and correct locations/conditions

Quality management

• Up-hold quality standards
• Ensure GMP/GLP is followed at all times
• Ensure all tasks and functions are performed in compliance with cGMP
• Constantly ensuring the quality of products by conducting stability studies
• Ensure operational compliance by management of non-compliance through review of root cause analysis and implementation of required corrective action within agreed timeframes
• Analyse systems non-conformances and elevate problems and /or solutions
• Monitor compliance to safety policies and procedures
• Compile SOP’s for new equipment / methods
• Continuously review existing SOP’s within the required timeframe
• Monitors maintenance and calibration programmes for the laboratory
• Ensure operational compliance by management of non-compliance through review of root cause analysis and implementation of required corrective action within agreed timeframes
• Perform calibration on instruments, always ensuring that calibrations schedules are adhered to
• Ensure appropriate maintenance of records
• Participate in internal audit programme to ensure effective functioning of the quality systems
• Provide training and assessment of new staff
• Attend meetings and training sessions as required, to remain informed of current field related developments and to promote knowledge sharing

Administrative tasks

• Perform any required administrative tasks in keeping with the smooth running of the department:
• File results for easy retrieval
• Archive documents regularly
• Ensures appropriate maintenance of records

Communication and co-ordination

• Liaise with suppliers – perform colour approvals at various printers
• Liaise with suppliers and instrument engineers
• Compile and submit reports timeously
• Provide effective feedback on investigations and progress
• Give informed opinion on instruments and testing when required

Core Competencies:

• Managing relationships
• Personal leadership
• Business impact
• Leading and influencing others
• Customer focus
• Leadership
• Problem solving/analytical thinking
• Technical/professional knowledge
• Accuracy/attention to detail
• Good communication (oral and written) and interpersonal skills

Qualifications:

• Bachelor’s Degree or National Diploma in Biochemistry, Chemistry, Biotechnology, Pharmaceutical science or related science field

Experience:

• 2 years analytical laboratory experience
• Computer literacy MS Office (Word, Excel, Power Point and Outlook)

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013