QA Executive

at  SUNWARD PHARMACEUTICAL PRIVATE LIMITED

JOB DESCRIPTION

• To ensure ongoing compliance with the PIC/S Guideline for GMP.
• To achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvement; implementing change.
• Develops and implements a practical system for Quality Management System activities to facilitate smooth, timely workflows in the performance of job function.
• To provide guidance, interpretation, information on regulations, laws and industry guidance that affect pharmaceutical industry.
• Serve as a SME in matters relating to quality assurance and cGMP.
• Ensure facility follows applicable quality management directives such as SOPs, manuals, policies, procedures, work instruction, etc.
• Responsible for reviewing, trending and investigating excursions of environmental monitoring and supportive utilities data.
• The inspection and investigation of product recalls and product complaints to look into factors which has affect product quality.
• Acts as the Authorized Person to perform batch release and ensure each batch of medicinal products are manufactured and checked in compliance with the laws in force in the country and in accordance with the requirements of the Marketing Authorization.
• Reviews, approves or authorizes written procedures and other documents, including amendments.
• Oversees various quality management systems and analyze trending.
• Reviews and approves deviations and CAPA.
• Review, approves and implement changes according to established Change Control procedure.
• Coordinates and participates in quality risk management activities.
• Initiates investigation for product complaints, reviews and approves corrective/preventive actions associated.
• Coordinates product recalls, associated reconciliation, documentation and investigations.
• Reviews, approves and monitors suppliers of materials.
• Reviews, approves and monitors contract manufacturers and providers of other GMP related outsourced activities.
• Ensures validation and qualification are carried out according to schedule.
• Provides training or ensures appropriate training is provided to QA staffs.
• Monitors compliance of the organization with the requirements of Good Manufacturing Practice via Internal Audit.
• Coordinates management reviews of process performance, product quality and Pharmaceutical Quality
• System and advocates continual improvement
• Ensures timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.

Requirements

• ISO/GMP in Pharmaceutical Experience will be prioritize
• At least bachelor degree, post graduate diploma in any science, or others filed related to pharmaceutical
• Minimum 7-8 years experience
• Well versed in computer skill especially in excel and other Microsoft office skills and knowledge in Navision is preferred.
• Close attention to details is essential
• Must be able to perform each essential duty satisfactory and in timely manner
• Independent & communication skills

Please refer the Job description for details