Officer-QMS / Executive-QMS

Role & responsibilities

• Responsible for planning and monitoring of day-to-day activities of Quality System in the plant.
• Preparation and implementation of Quality System SOPs,and WI instructions.
• Prepare and regular updation of Quality Manual, Site Master File and related policies or procedures.
• Support Manufacturing and other teams to prepare and implement the Equipment and General SOPs.
• Review and control of SOPs, STPs, Specifications, Batch production records, Log registers and raw data sheets.
• To conduct quality related trainings.
• Register Change control, Deviation, OOS, CAPA, Quality Risk Assessment and Market complaints.
• Track and trend CAPA, change controls, deviations, quality system documents and implementation of the same.
• Responsible for preparing the Annual Product review for all products.
• To conduct Self inspections and archival of its reports.
• To provide support in audits.
• Facilitating sharing of best practices including global standards.
• To review the executed Batch production records for product release.
• To investigate the product recalls/complaint report and implementation of CAPA.
• Overall responsible for the issue and archival of all types of Quality documents of plant.
• Prepare the monitor the Quality Matrix for the plant.
• In-depth understanding of regulatory requirements, exposure to all the regulatory guidelines and first hand exposure to regulatory audits.

Supporting Responsibilities

• Ensure support in execution of any Quality oriented project assigned by Lead / Head Plant Quality Operations from time to time.
• Support Lead / Head Plant Quality Operations for tracking & meeting established department and project goals and budgets

Preferred Candidate Profile :

Experience of working in a similar Quality Assurance related role in the Healthcare/Food/Pharma Industry

Internal Audit/Lead Auditor certificate in FSSC 22000, ISO 9001

• Knowledge of QMS implementation as per applicable regulations
• Experience of conducting quality-based investigations and root-cause analysis Knowledge
• Understanding and experience of Change Control, stability study, validations, GMP & GLP.
• Understanding of Product Quality Review requirements
• Knowledge in Food Safety and HACCP
• Planning, organizing, coordinating and monitoring skills
• Analytical & problem solving
• Team player
• Communication Skills and customer Orientation
• Decisive thinker able to work within agreed timescales
• Proficient in Excel and Word