QMS Officer

JOB DESCRIPTION

Title: Officer - QMS

Location: Madurai Manufacturing Unit

JOB SUMMARY

Purpose

To provide direct support to the QMS Lead in the management of the day to day aspects to ensure effective Quality System Implementation at Madurai Manufacturing Facility. The position will be responsible for QMS related documentation, support in all audits and projects.

Primary 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

REQUIRED KNOWLEDGE, SKILLS, ABILITIES AND/OR RELATED EXPERIENCE*
* or an equivalent combination of formal education, on-the-job training, and/or work and life experience

Education: M. Sc. / B. Tech / B. Sc.

Food Science / Pharmacy / Microbiology / Chemistry / Biotechnology / Bio chemistry

Required Knowledge, Skills, Abilities and/or Related Experience:

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

• 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