Vice President - Quality and RA (OSD)

Role & responsibilities

• Heading the Quality Assurance, Quality Control and Regulatory Affairs Department.
• Conducting Regulatory compliance inspections/ audits.
• Corresponding with authorities on deficiencies / queries on ANDA/ANDS/MAA and DMFs filed.
• Post approval changes submission to the ANDA/ANDS and MAA.
• Develop and maintain appropriate written standard operating procedures to provide management documented procedures as to how the Quality Unit executes its responsibilities.
• Responsible for the implementation of Quality Systems.
• Responsible for ensuring compliance to the requirements on CGMP and GxP as per the updated guidelines ICH Q7, WHO, Schedule M, 21CFR, EU, ISO and all other relevant regulations.
• Responsible for batch release / rejection to market.
• Responsible to make sure that quality related complaints, return goods and recalls are investigated and resolved.
• Making decision to recall the product from market in consultation with top management.
• Responsible for review and approval of technical / Quality agreements with customers.
• Responsible for risk identification, evaluation, communication and approval of reports related to the specific process / system / equipment / instrument.
• Maintaining customer correspondences.
• Ensure all the New product introduction, LL Product and Customer product are meeting the GMP Requirements.