Laeeq Ur Rehman Malik

QUALITY

• Reorganized and revised standard operating procedures to streamline processes and improve communication and collaboration.
• Coordinated and reviewed product-related market complaints and insurance claims.
• Updated controlled documents and artwork for packaging materials.
• Trained staff on quality-related documents.
• Managed field alerts and product recalls.
• Conducted vendor audits and addressed quality-related queries.
• Served as the primary contact during external audit reviews.

REGULATORY

• Reviewed product labeling materials for regulatory compliance.
• Facilitated correspondence and addressed product-related issues from RRA.
• Responsible for the submission of documents for audits and good distribution practices for devices and therapeutic goods.
• Provided guidance on complex regulatory issues to senior management and other departments.
• Supported training and handling of product-related ADR and patient safety events.
• Analyzed regulatory documents for compliance with laws and regulations.
• Managed the preparation of CTD dossiers for local regulatory authorities.
• Handled controlled correspondence with RRA and principal through various communication channels.
• Reviewed and proofread promotional and non-promotional materials for accuracy.

MEDICAL COMMUNICATION

• Critically evaluated documents to ensure scientific and regulatory compliance and validate product claims.
• Provided scientific insights and training to relevant stakeholders.
• Conducted research studies to substantiate claims.
• Offered medical and regulatory support for projects within Consumer Care.
• Performed comprehensive reviews of artworks, labels, package inserts, and promotional materials.
• Assessed queries in accordance with regulations and technical specifications.

• Ensured GDP in finished product and dispatch areas.
• Reorganized and revised standard operating procedures to streamline processes and improve communication and collaboration.
• Handled and coordinated product-related market complaints and insurance claims.
• Supported the regulatory department in conducting audits and routine inspections.
• Conducted routine reviews and updates of controlled documents and artwork for packaging materials.
• Coordinated and managed field alerts and product recalls.
• Conducted vendor audits and facilitated quality-related queries with new and existing vendors.
• Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
• Compiled regulatory submissions for timely registration of new products and renewal of on-market products.
• Reviewed product labeling materials for compliance with applicable regulations and standards.
• Supported routine correspondence and addressed shortcomings related to products from RRA.
• Handled online submission, approval, and clearance of import applications.
• Provided support in training and managing product-related ADR and patient safety events.
• Regularly reviewed and proofread promotional and non-promotional materials to ensure the presence of essential information.

• Conducting vendor audits and assisting suppliers with quality and product-related queries.
• Supporting Quality in conducting Audits and Routine Inspections.
• Corresponding monthly reports on product and packaging-related issues for deviation closeout and assisting in CAPA recommendation.
• Ensuring In-Process monitoring in production operations.
• Assisting the Change Control owner in the proper execution of change control and managing related queries.
• Assisting in providing product-related queries to Regulatory Authorities (RRA).
• Handling and coordinating product complaints related to Market and Distribution sites.
• Performing monthly complaint trend analysis.
• Ensuring Good Distribution Practice (GDP) in Finished Product and Dispatch Areas.
• Facilitating Business Development (BD) in Product Dossier and Technical queries.
• Reviewing and approving printing and repacking activities.
• Reconciliation and batch disposition of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
• Establishing quality procedures and conducting routine review of controlled and other Good Manufacturing Practice (GMP) related documents.
• Maintaining up-to-date knowledge of company and federal regulations to ensure product quality, consistency, and compliance.

• Supervise manufacturing-related Quality Assurance (QA) and Production operations, ensuring compliance with GMP guidelines.
• Manage and control documentation for Quality Systems, ensuring accuracy and compliance with GMP policies and procedures.
• Conduct audits to ensure adherence to company policies and GMP regulations.
• Support product development and oversee product control processes.
• Address regulatory issues and coordinate with regulatory authorities on new requirements.
• Collaborate with the marketing department to create and maintain a product surveillance system.
• Coordinate the compilation of New Product Development (NPD) registration with relevant authorities, including the Ministry and other organizations like DRAP and Council Union.
• Assist in proofreading and obtaining approvals for packaging and promotional materials.