Gmp Auditor - Pinetown, South Africa - NBISA Recruitment

NBISA Recruitment

Verified Company

Pinetown, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Job Advert Summary:

To support NBI Mission, vision, core values, quality objectives and quality management system through effective selfinspections and vendor audits. The purpose of the position is to ensure organisational compliance with current GMP, relevant ISO standards and regulatory requirements through an effective audit function.
To ensure that internal audits are planned, conducted and reported in a manner that is compliant with NBI's quality management system, relevant ISO standards, current GMP and regulatory requirements.
To monitor the implementation and compliance with relevant ISO standards, current GMP principles and to propose necessary corrective and preventive measures.
To conduct audit checks on Biotech Manufacturing documents and ensure closure of queries.
To form part of a team to conduct audits on NBI vendors.

Specific Operational Requirements

May be required to work overtime to meet the business needs.
Must be prepared to work shifts/weekends/public holidays when needed.

Specific SHE Requirements

Preemployment, routine, and exit medicals are compulsory due to the nature of the business.
Attendance to SHErelated training is mandatory.
Adherence to SHE Instructions (Waste Segregation, Water and Energy Saving Initiatives)
Compliance with SHE Site Rules is compulsory.

Minimum Requirements:

Bachelor's degree or related qualification in Chemical Engineering, Chemistry, Biochemistry, Biological, Pharmaceutical Science or related field
A minimum of 3 years experience in the pharmaceutical manufacturing or similar environment, with knowledge of pharmaceutical facilities, equipment, processes, laboratories and Quality Management systems is required.
Good working knowledge of auditing in principles in an ISO and GMP environment.
Hands on experience with internal and vendor audits preferred.
Knowledge of PIC/s and SA current GMP guidelines, QMS principles and international standards (e.g. ISO9001, ISO13485, ICH10) is preferred.

Duties and Responsibilities:

Quality Managements Systems (QMS):

Responsible for the implementation and maintenance of an internal audit programme that ensures that NBI quality management system is complied with and that regulatory requirements are satisfied.
Responsible for conducting internal and vendor audits and reporting in accordance with the set annual audit programme.
Review of documents as required
Usage of the audit notification system on SAP to track audits and audit findings.

Implementation and maintenance of systems to ensure effective internal audits

In consultation with the Quality Assurance Systems Officer, draw up annual internal audit programme ensuring that all aspects of NBI's quality management systems are covered.
Conduct internal audits of the various areas within NBI to assess their compliance with current GMP, ISO 13485 where applicable, and other applicable requirements. This includes planning, conducting and reporting the results of these internal audits with subsequent follow up on any agreed corrective and preventive actions.
Ensure that opening meetings are held prior to the audit to discuss purpose and extent of audit and closing meeting is held after the audit is conducted to discuss observations and corrective action to be implemented.
Write final report on internal audits conducted using the classification system as described in internal SOPs and QOPs in a timely manner.
Raise audit related notifications on the SAP system as appropriate.
Ensure that corrective actions are received from departments audited, to correct deficiencies in accordance with agreed time frames. Conduct follow up audits where required to verify that corrective actions have been implemented.
Ensure that relevant parties are kept informed of all audits and followups conducted. Supply information regarding all audits conducted and progress on corrective action implementation to QA Systems Officer and QA Manager as required for Quality and audit review meetings.
Communicate timeously internal audit results to management and auditees through written audit reports, as described in internal SOPs and QOPs.
Conduct regular followup on all internal audits in accordance with set deadlines, ensuring that the Quality Assurance Systems Officer, Responsible Pharmacist as well as QA manager are kept informed of deadlines that are exceeded.
Responsible for preparation prior to conducting audits to ensure that all aspect will be covered during the audit
Responsible for conducting audits as determined by the audit programme as well as conducting audits as required resulting from an investigation into an incident, deviation, vendor or customer complaint.

Review of Biotech batch records

Review all batch related records from EPU and Biotech in conjunction with ISO 13485 requirements.
Preaudit records before final audit conducted by QA manager for product release.
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