Job Summary

The Head of Technical Compliance is expected to adhere with the cGMP principles and to maintain them in an effective manner. He will be responsible for the compliance of the systems and procedures in all the Plants of the company and to ensure that effective measures being taken for Good Documentation practices. He will also be responsible for vendor approval of Raw and Packaging Material as well as the supervision of batch document review team and final checking of the finished product prior to shipment. Moreover, he will be responsible to face external quality audits and answer the questions raised by auditors regarding batch documents.

Main Responsibilities:

• Responsible to work as independent body under Executive Director to review and evaluate compliance issues.
• Responsible to ensure that rules and regulations of regulatory agencies and company policies and procedures are being followed through internal audits and regular inspections.
• If required, works in coordination with other departments to ensure the achievement of the objectives.
• Assists Executive Director to ensure that compliance issues within the organization are being appropriately evaluated, investigated and resolved.
• If necessary, coordinates with other departments in identifying the potential areas of compliance vulnerability and risk, develops / implements corrective and preventive plans to avoid similar situations in future.
• Ensures proper reporting of potential violation to Executive Director.
• Assists Executive Director to follow the implementation of compliance related corrective actions on a continuing basis, suggesting appropriate steps to improve their effectiveness.
• Leads Documentation group to streamline the batch documentation thorough audit function for all dosage forms.
• Responsible for Good Documentation Compliance in general.
• Responsible for arranging and supervising complete batch documentation review during all kinds of audits.
• Responsible for vendor approval of Raw and Packaging Materials.
• Directly involved in finished product shipping and supervise the inspection staff to assure correct product with correct quantity to be dispatched to the consignee as per the shipping invoice.
• Performs any other responsibility to assigned by the Executive Director.