Job Description

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 alarmsData 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 2025If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.Disclaimer:Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Biovac