QC Supervisor
Cipla Africa
Job Purpose
The incumbent is responsible for management of the analyst with respect to planning, allocation of work as per operation requirements to support the business for raw material and packaging including management of sampling of both raw material and packaging material. The incumbent shall allocate the review of all analytical data generated during the analysis of raw material and packaging materials and special request (non-routine) samples to meet the production requirements and business needs in accordance with laid down procedures. The incumbent is responsible for quality and safety as per the business written procedure and targets.
Key Accountabilities
People Management
- Manage the team timekeeping, leaves and shift schedule.
- Assist with disciplinary procedures, recruitment and retention of staff.
- Encourage the teamwork spirit and motivate the team.
- Communicates effectively with staff, internal departments & external clients to ensure timeous resolution of queries.
- Manage the talent and delegate effectively
- Manage diversity.
- Develops capacity within the section.
Skills & Knowledge
- Training and development of the team
- QC Management
- To plan and schedule the workload of the instrument laboratory and ensures that the QC laboratory maintains GMP Compliance, safety standards and good housekeeping.
- To ensure that Raw material and Packaging Materials and special request (non-routine) are sampled and tested according to prescribed monographs and meet specification prior to use.
- Update SOP as required for the respective processing and product testing
- Initiate and drive change controls for artwork, new monographs, CAPA’s from internal and external audits, and continuous improvement initiatives.
- Review of work output report and analyst performance
- Monitoring routine analysis of samples and confirmation of results, when required.
- Participate in the management the laboratory maintenance, validation & calibration programme to ensure timeous availability of instruments for analysis
- Manage QC resources to ensure optimum productivity.
- Ensure filing of all retention samples in accordance with the relevant SOP. Ensure that packaging materials have defined and approved specification.
- Ensure timeous sampling, testing and release of packaging materials and raw materials.
- Ensure that the filing systems are maintained in a controlled and orderly manner.
- Checking of raw data and analytical results for approval/rejection, when applicable as per procedure.
- Daily allocation of work to the analyst of analytical
- Review of trend reports for APQR.
- Release and reject material on SAP.
- Checking trend cards/ electronic system are correctly completed and available at time of release and evaluating the data for batch disposition
- Good Laboratory Practices
- Adherence to laboratory best practices to ensure testing is conducted effectively
- To ensure destruction of expired samples and tested and released samples.
- Ensure that the department is maintained in a clean and orderly manner i.e. good housekeeping.
- Ensure safety precautions while working in area and that appropriate PPE is always worn.
- Technical Support
- Ensure SOP training and analyst qualification is conducted to improve efficiency testing time.
- Offer technical evaluation for new vendor introduction, technology transfer and method validation/verification requirements
- Ensure analytical equipment are calibrated and qualified,
- Responsible for providing technical support and analytical training to Quality Control personnel.
- Oversee first line trouble shooting on QC laboratory processes (equipment, materials) and delegate corrective actions to QC personnel.
- Ensures development of improved analytical methods to the latest monograph.
- QC Systems
- To ensure compliance of equipment, SOPs, internal/external findings and investigate non-conformances.
- Implement robust CAPA relating to OOS/OOT/incidents to prevent re-occurance
- Support implementation or introduction of new systems to support automation and improve quality.
- Ensure that all monographs and SOP’s are as per latest compendia
- Assist in handling of customer complaints by providing technical support and reports
- Discussion of out-of-specification and out-of-trend test results with the Quality Control Manager, initiation of investigation of results and submission of additional results.
- Preparation of protocols and reports for packaging trials and new vendor registration
- Conduct self-inspections when required.
- Artwork – initiating change controls and facilitating changes – getting approval where appropriate.
- Designing packaging configurations, as required.
- Investigates non-conformance (OOS/OOT/Rejections) related to packaging materials and packaging related production line problems.
- Liaising with Supply Chain and coordinating new packaging components.
- Liaising with suppliers and customers for changes to specifications.
- Reviewing BPR’s for correct stock code and proof numbers.
- Initiate rejection procedure