Q.A Document Control Lead Manager

Supervising quality assurance documentation and compliance personnel, preparing and participating in the quality assurance activities including SOP and specification revision, deviations, change controls, release process, rejection process, annual product quality review, batch record drafting and preparation, batch record issuing, customer complaint and supplier qualification, site master file, quality manual, export cycle revision, internal audit, media fill batch record issuing and creating, recall and mock recall process.

Key Responsibilities:

• Issue, maintain, and design SOPs concerning the quality assurance department or other departments with common interfaces.
• Prepare and implement quality policies.
• Responsible for document control and record control activities.
• Issuing and distributing controlled documents and withdrawing the obsolete and invalid versions, including approved procedures and SOPs, specifications, methods of analysis, batch records, protocols, and plans.
• Perform all the required document updates for GMP documents for all departments.
• Prepare the list of approved documents and document status regularly.
• Perform change control activities, including assigning tracking numbers, routing, tracking, expediting change control, distributing new documents and retrieving obsolete ones, performing changes to text documents, and reporting on change control status to management.
• Participate in the implementation of the quality coding system.
• Follow up on change control actions on the computerized system.
• Review specs (raw materials, primary, and secondary packaging from quality control to release).
• Issue and create batch manufacturing records and batch packaging records.
• Assure all documents are reviewed for compliance with cGMPs and company policies periodically.
• Participate in the internal and external audits.
• Review and approve the specification of raw material, primary packaging, secondary packaging, and FP.
• Apply statistical process control tools for the data collected with the purpose of continual improvement.
• Collect data and apply statistical process control tools to prepare a PQR (product quality review) for every product.
• Collect all department data related to SMF (site master file) from the machine list, utility list, QC machine list, and organization charts that are used in production, quality control, research and development, engineering, and quality assurance.
• Receive the BOM of the packaging materials from the planning department to be checked for the correctness of the item codes.
• Review and approve the layout of the manufacturing, store, and administrator site.
• Collect all department data related to the quality manual or IMS (integrated management system), which matches with ISO standards.
• Issue and create a media fill batch record and review it with the batch manufacturing record to ensure the media fill batch record mimics batch manufacturing in the process. 
• Responsible for recall procedure investigation and the design of the recall, informing all related destinations, making reconciliation, and following up on the recalled quantity.
• Responsible for mock recall to mimic the actual recall.
• Responsible for receiving the complaint and investigating it and detecting the root cause, and putting corrective and preventive actions in place.
• Participate in the documentation cycle of the validation activities.
• Train newly hired employees properly, ensuring their ability to perform all types of tasks assigned efficiently and enhancing their skills to the approved standard.
• Formulate and recommend technical training programs based on knowledge of identified training needs, company production processes, or changes in products, procedures, or services.
• Follow up, maintain, and ensure implementation of safety instructions and requirements in certain areas.
• Follow up, maintain, and ensure implementation of GLP, GMP, and GDP rules.
• Shall be consulted and participate in and enforce subordinates’ implementation in the EHS management system and its improvement elements via reporting actions/incidents that could occur or have occurred, and attend the relevant trainings.