GMP compliance and internal audit section head

BioGeneric Pharma S.A.E (BGP)

The ideal candidate will be responsible for establish the audit program and assign to each team member responsibility for auditing specific processes, activities, functions or locations., with a track record of success in the pharmaceutical industry.

Key Responsibilities:

Prepare risk-based audit program annually.
Establish the audit program and assign to each team member responsibility for auditing specific processes, activities, functions or locations.
Revises the relevant audit plan and informs the auditee before the planned time of the audit.
Performs the opening meeting and facilitate the closing meeting.
Ensures that audit activities are recorded properly.
Confers periodically to exchange information, assess audit progress, and reassign work between the audit team members as needed.
Issues the wave audit report [for each audit wave] as planned.
Ensure conduction of the audits in accordance with the audit programs and within the agreed time frame.
Issue list of auditors on yearly basis or whenever changes do occur.
Assure training conduction throughout the year, at least training each quarter for the guidelines and best practices in GMP/ISO auditing.
Prepare semiannual audit activities overview to be reported as an input for the management review.
Follow up corrective action s implementation.

Responsible for auditing process as an auditor with the following responsibilities:

Prepares plan for each activity, process, function or location assigned to him/her to be audited.
Generates audit findings and reports non-conformities identified during the audit.
Prepare and document the audit checklist.
Provide recommendations for the auditee, if needed, discuss and agree on CAPAs for the reported nonconformities with the auditee.

Qualifications:

Bachelor s degree in Pharmaceutical Sciences
At least 8 years experience in the compliance field of a sterile bio/pharmaceutical company
ISO awareness regarding the following standards ISO 9001:2015 for Quality Management, ISO 14001:2015 for Environmental Management, ISO 45001:2018 for Occupational Health and Safety Management, and ISO 27001:2022 for Information security management systems in an integrated management system.
Certification as an ISO auditor is a plus.
Leadership and team building skills.
Ability of planning, prioritizing and project management
Effective communication with various levels
Decision maker
Ability to measure performance and effectiveness of different processes.
Able to manage changes.
Strong communication skills and extremely self-motivated when managing communication channels.