Quality Documentation Manager

Role & responsibilities

Job Profile

• MANAGEMENT SYSTEMS CERTIFICATION SERVICES OFFERED :

• • ISO 9001: 2008 Quality Management System Certification.
• • ISO 14001:2004 Environment Management System Certification.
• • ISO 22000:2005 Food Safety Management System Certification.
• • ISO 27001:2005 Information Security Management System Certification.
• • OHSAS 18001:2007 Occupational Health & Safety Management System Certification.
• • ISO 13485:2003 Medical Devices - Quality Management System Certification.
• Documentation & Document Control as per

  ISO 9001, EMS 14001, OHSAS 18001 &

• WCM.

• •Implementation & improvements of Quality System.
• •On Job Training schedule & refresher training of Quality Control personnel.
• •Generation & reporting of monthly QC report.
• Documentation & Document Control as per

  ISO 9001, EMS 14001, OHSAS 18001 &

• ISO 17025 (NABL).

• •Implementation & improvements of Quality System, GLP.
• On Job Training schedule & refresher training of Quality Control personnel.
• •Authorisation of Approval/ Rejection of incoming , In-Process &
• Finished Products at all defined stages of activities to meet & maintain the quality of
• product.
• •To motivate, develop & retain talent in improving quality & quantity of working.
• •Monitoring the root cause of quality problems & implementing systematic solution.
• •Recommending action on non conforming products.
• •Preparing performance appraisal of sub-ordinates.
• •Review of STP, SOP, Method Validation protocols and take steps for improvements
• monitoring the compliance levels.
• •Establish shelf life and storage requirements on the basis of stability tests results.
• •Developing the competency levels of the employees and guiding and conducting
• regular training programmes for ISO, EMS. OHSAS, GLP & SOPs.
• •Handling of Various Quality Notification like O.O.S, Change Control, Deviation,
• Self inspection,Incidents / Investigation and impact analysis of same.
• •Distribution and reconciliation of the work for the day, strict compliance of SOP,
• housekeeping, documentation and safe practices.
• Monitoring QA & QC activities.
• •New product development & Process improvement.
• •Responsible for customer queries & complaints and developing corrective action
• plans as well as formal customer responses.
• Preparation of Monthly Laboratory Performance Report.
• Looking after Quality Control & Quality Assurance.
• •Implementation & improvements of Quality System.
• •Training schedule & refresher training for Chemist.
• •Documentation & Document Control as per WHO-GMP.
• •Maintaining Inspection, Testing, Approval, Rejection of incoming , In-Process &
• Finished Products at all defined stages of activities to meet & maintain the quality of
• product.
• •To motivate, develop & retain talent in improving quality & quantity of working.
• •Monitoring the root cause of quality problems & implementing systematic solution.
• •Recommending action on non conforming products.
• •Preparing performance appraisal of sub-ordinates.
• •Review of STP, SOP, Method Validation protocols and take steps for improvements
• monitoring the compliance levels.
• •Developing the competency levels of the employees and guiding and conducting
• regular training programmes of GMP, GLP, SOPs.

Preferred candidate profile

Perks and benefits