QC Manager
Job Location:
Durban - South Africa
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Job Purpose
Lead the overall operations pertaining to the Quality Control Laboratory in relation to staff quality and operations. Provides high quality service and technical expertise to internal and external customers and performs the functions associated with the Quality Control Laboratory (excluding Microbiology and Compliance team)
Key Accountabilities
People Management
Manage the team timekeepingleavesand overtime.
Assistwithdisciplinary proceduresrecruitmentandretention of staff.
Encourage theteamworkspirit and motivate the team.
Communicates effectively with staff departments & external clients to ensure timeous resolution of queries.
Manage the talent and delegateeffectively
Manage diversity.
Undertake project work within the operationalobjectivesof the organization.
QC LaboratoryManagement
To ensure and increase the efficiency in the QC laboratory.
Ensuresthat the QC laboratorymaintainsGMPCompliance safetystandardsand goodhousekeeping
Continuous improvement of processes / validation.
Accurate assessment of data and decisions taken by QC analystsand microbiologist.
Responsible for the final release of all QC test results.
Responsible forappropriate actionon all QC data through the development and implementation of systems to improve processes and tests.
Accurate assessment of laboratory requirements such as equipmentandconsumables.
Review anomalies and propose corrective actions.
Communicates effectively with other staff departments & external clients to ensure timeous resolution of queries.
Manage the laboratory maintenance validation& calibrationprogramme
Monitoring routinesampling andanalysis of samples.
Review andCheckthe logbooks/Preparation of laboratory solution.
Review and approvalof analytical reports of chemical testingfor batch release
Preparation/Review of specifications or monographs.
Review of trend reports forAPQR
Preparation ofcertificate ofanalysis for post importation products and providing certificates tocustomer.
QC Systems
To ensure compliance to current guidelines.
Ongoing development evaluation & implementation of quality control testing programmes in conjunction withRegulatoryQAproductionandCustomers
Ensure thatappropriate actionis taken and preventedin the event ofnon-compliance(OOS/OOT/Analytical Incidents)
Ensure that major deficiencies errors deviation from SOPs compliance with QC programs andGMPare in line withappropriate measures.
Responsible for successful implementation and maintenance of quality control systems in laboratory including CAPA vendor approval validation document control.
Survey the environment to keep abreast of latest regulatory requirement so that all documents are in adherence to currentGxPsystems
Technical Support
To ensure the competency and support to the team or external stakeholders.
Providedirectionfor continuous improvement and simplification of processes/documentation.
Support QC staff and manufacturing to resolve QC related problems.
Performaccuratestatistical analysis andevaluation oftrend analysis on tests & results.
Ensure ongoing research validation & evaluation of test methods equipment & processes.
Ensure that the analyst qualification is conducted.
Provide environment to team members to develop their potential by involving them in major discussions/trainings.
Overseetroubleshooting on QC laboratory processes and delegate corrective actions to QC personnel.
Ensure that the technical/method transfersand methodvalidation
Educational qualifications:
BSc Chemistry/DegreeAnalytical Chemistry (or Equivalent)
Relevant experience:
6-8 years of experience in QC department of a pharmaceutical organization with knowledge of latest regulatorystandards and compliance norms
Required Experience:
Manager
About Company
Cipla is a market-leading medicine maker in India. The company has roughly 5,500 pharmaceutical products. Some are sold domestically, while the rest reach international markets in some 170 countries. It offers prescription drugs for all kinds of ailments -- arthritis, cancer, depressi ... View more
