Control Room Operator at Biovac

About the job Control Room Operator

• BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Control Room Operator to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Minimum: Grade 12

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 2 Years experience in the pharmaceutical industry would be highly advantageous.
• Knowledge of a sterile manufacturing or pharmaceutical environment would be an advantage.
• Knowledge of computerized systems and computer literate.
• Sound technical ability and hands on approach.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Ensure cGMP implementation daily on work instructions.

Monitoring Systems:

• Management of the Control Room Systems to ensure that it is used according to the correct procedures.
• Continuous monitoring of the Control Room to ensure that area is in a state of compliance.
• React to alarms associated with the Particle Monitoring System (PMS) and Data Management System (DMS) and Clean and Industrial Utilities action corrective actions.
• Manage the printing of monitoring data.
• Initiate and investigate deviations related to monitoring systems.
• Perform the following related to monitoring systems:

Access Control:

• Ensure that the system is in a state of control and all access is current.
• Grant access for entry into all facility areas via Dept Head.
• Management of the access control systems and assessment of the audit trails when requested.
• Addressing system faults and errors.

PMS System:

• Ensure that the system is always in a state of control and operational.
• Ensure that daily monitoring is executed.
• Printed of PMS reports for batch related activities.
• Retrieval and review of the audit trails when requested.
• Addressing system faults, error and acknowledgement of alarms.

DMS/BMS System:

• Ensure that the system is always in a state of control and operational.
• Ensure that daily monitoring is executed.
• Printed of DMS/BMS reports for batch related activities.
• Retrieval and review of the audit trails when requested.
• Addressing system faults, error and acknowledgement of alarms.

Clean/Industrial Systems:

• Ensure that the system is always in a state of control and operational.
• Ensure that daily monitoring is executed.
• Printed of DMS/BMS reports for batch related activities.
• Addressing system faults, error and acknowledgement of alarms.
• CCTV Systems
• Ensure that the system is always in a state of control and operational.
• Ensure that daily monitoring is executed.
• Retrieval and review of the audit trails when requested.
• Addressing system faults, error and acknowledgement of alarms

Data Backup Systems:

• Ensure that all relevant Engineering data is backed up as per procedure.
• Evaluate if data is being backed up as per procedure.

Compliance:

Monitoring Systems:

• Communication to the team leader or Supervision if an alarm has occurred.
• Action corrective actions to allow manufacture to continue.
• Deviations, CAPAs, and Change Controls:
• Reporting incidents to the affected departments within the desired reaction time.
• Knowledge of the department process to prevent deviations in manufacture.
• Deviation initiation and closure.

Engineering Administration (Support Role):

• Ensure cGMP implementation daily on work instructions.

Engineering Documentation:

• Printing, closing and archiving all engineering logs.
• Management and distribution of all engineering documentation i.e. SOP files.
• Coordination of the monthly expiring SOP list from QA and to ensure that all documents are assigned to prevent expiration.
• Management of equipment cycles to ensure that all cycles are reconciled on a daily basis and filed within the required time frame.
• Updating of documentation where required i.e. via the Change Control System.

Quality Performance in Terms of:

• Building GMP Knowledge and Compliance.
• Building Quality Culture.
• Establishing and maintaining a state of Control.
• Driving innovation and Continuous Improvement.
• Driving Quality Risk Management.
• Ensuring that area of responsibility is audit ready, closing audit findings.
• Managing Deviations, Change Controls, CAPAs
• Quality Objectives: Drive the quality objectives.
• Understanding and practicing of quality assurance aspects and good documentation practices at all times.

Communication:

• Ensure a timely and effective communication.
• Escalate quality issues to the appropriate levels of management.
• Improvement: Advocate continual improvement within department

Application Deadline:

• 16 May 2025