QA Lead Responsible Manager

Company Name Confidential - QA Lead Responsible Manager

• Responsible for performing Quality Assurance (QA) activities for the commercial products at the affiliate and its business partners comply with the applicable local regulatory requirements and our company global and regional requirements.

• Manage the product quality complaints in Track Wise system for the products and establishes communications with the manufacturing site QA and complainant
• Manage a pharmaceutical technical defect risk and notifies Sub-Region Lead QA about an identified product recall.
• Manage the deviations in Track Wise and escalates major/critical deviations to Sub-Region Lead QA.
• Prepare monthly Key Performance Indicators (KPI) for the previous calendar month and shares with Management Team and Sub-Region Lead QA.
• Act as a contact point for QA audits/inspections.
• Give active support in case of any company audits/inspections.
• Manage quality audits of local country third party facilities providing GMP/GDP activities.
• Manage change request according to specific applicable local/global procedures.
• Manage CAPAs in accordance with local/global requirement.
• Participate in the qualification system to support mock product recall process.
• Escalate any significant quality issues to Sub-Region Lead QA in a timely manner.
• Manage returned products in accordance with local/global procedures.
• Direct product quality issue resolution to responsible division and provide an oversight of the overall quality system.
• Manage GMP/GDP operations in the warehouse of Local Service Providers.
• Identify, evaluate and control the potential risks associated with real or potential GDP related with the product, patient safety, data integrity and quality system issues.
• Manage re-packaging operations according to applicable local/global procedures.
• Prepare, establish and maintain local SOPs and according to applicable local/global procedures.
• Manage all Quality Agreements with our company manufacturing plants and business partners as necessary
• Perform review of product quality reviews (PQRs) for the products where APTR is the marketing authorization holder (MAH).
• Communicate with the Health Authority as necessary in regards to Quality Assurance aspects.
• Maintain contact with customers and manufacturing sites in relation to QA activities of products which are distributed by in APTR.
• Train affiliate personnel in the requirements of the Quality Management System such as complaint handling procedure, deviation handling procedure, etc. and maintaining training records.
• Provide QA training to new comers in scope of orientation programme.
• Notify APTR Drug Safety on any our company drug safety issue and be in coordination with PV to take measures to implement any necessary risk management plan for the our company product in their responsibility.
• Archive all QA related documents according to regulations and procedures.

• Minimum 4 years university graduation from pharmacy, chemical engineering, chemistry, biology, genetics or other suitable education for specialist position.
• To behave ethically and professionally with customers and colleagues
• Analytical thinking
• Result oriented
• Patient focus approach
• Team Oriented, collaborative
• Effective planning and organizational skills, attention to details and excellent follow up skills
• Fluent English
• Good computer skills in MS Office applications