Quality Management System Officer - City Of Johannesburg Metro Verfied

Salary Negotiable City Of Johannesburg Metro, Gauteng City Of Johannesburg Metro, Gauteng more than 14 days ago 14-02-2019 10:33:10 AM
11-04-2019 10:33:10 AM
MINIMUM SKILLS AND KNOWLEDGE REQUIRED :
• Science Degree
• Relevant experience in QMS
• Good verbal and written communication ability (English)
• Working knowledge of Syspro
• Must have experience in the Pharmaceutical industry at production and QA level

BEHAVIOURAL DIMENSIONS REQUIRED :
• Team player with high regard for quality
• Ability to work effectively under pressure
• Deadline orientated & Good eye for detail & Ability to multitask
• Good Planning & organizational skills
• Must be good at follow up
• Self motivated, Organized & disciplined work Ethics
• Good interpersonal skills
• Attention to detail
• High level of accuracy & numeracy

BRIEF DESCRIPTION OF KEY PERFORMANCE AREAS :
• Internal Audits
o Responsible for compiling, issuing and updating of annual inspection schedule, ensuring that all critical aspects of pharmaceutical manufacturing are covered.
o Ensuring that audits are performed as scheduled and where necessary are rescheduled.
o Ensuring that all audits findings are documented and distributed within the time frame as specified in the procedure.
o Arrange follow-up audits and issuing of follow-up reports detailing completed and outstanding corrective actions.
o Ensuring all finding and actions are captured into a control data base and ensure that follow up of corrective actions are captured.
o Issuing updated monthly audits trending report detailing all aspects.
• Deviation
o Issuing of an updated monthly deviations trending detailing all aspects.
• Vendor Audits
o Scheduling annual vendor audits and compiling the annual schedule.
o Performing vendor audits as and when required and as detailed in the SOP.
o Compiling the vendor audit reports and arranges follow-up CAPA with Vendor.
o Ensure all finding action are captured into a control data base and ensure that follow up of corrective action are performed.

• Customer Audits
o Assist in preparation and execution of customer audits.
o Ensure that all reports are compiled, and all findings and actions are captured into a control data base, track that all CAPA actions are completed as per agreed due date.
• Documentation
o Initiates, reviews and authorizes SOP’s relevant to the job function.
o Co-ordinating the filing of all quality records generated by the quality system within two weeks of receipt.

• Customer Complaints
o Co-ordination of investigation, implementation of corrective action and compiling of the reports for submission to the applicant within the specified time as per SOP.
o Ensure that all queries are followed up and resolved in the shortest possible timeframe with policy framework.
o Ensure that all material related complaints are forwarded to the supplier.
o Issuing of updated monthly trending report, detailing all aspects relating to customer complaints.
o A professional attitude is displayed when responding to a customer’s needs.
• Quality System
o Ensure that QMS tracking is performed monthly and communicated to all relevant departments (Change Control, CAPA’s , Investigations, Deviation, Risk Assessments, AQL’s MRB’s OOS’s OOT’s Reprocesses)
o Support QA function to compliance with regulations.
o Compile and ensure that an annual review of the quality system is performed.
o Responsible for the co-ordination and tracking of CAPA’s
o Responsible for the co-ordination and tracking of MRB point and issuing of minutes.
• Customer Service
o Queries to be followed up and resolved in the shortest possible timeframe within policy framework.
o A professional attitude is displayed when responding to a customer’s needs.
o Methods for improving customer services are proposed, developed and continuously updated.
o Ensure internal and external customers are constantly updated as to the progress of their queries.