Qms Coordinator

Role & responsibilities

Quality checks

Ensure raw material, packing material, consumables material checking

Ensure Work In Progress (WIP) check

In process quality check and correction feedback

Quality process adherence audit

Ensure Final quality monitoring

Preparing samples as per customer requirement

Preparation of COA/ other documents required for samples

Implementing CAPA recommendations and recommend trainings required

Ensuring consistent quality by establishing GMP systems, validating processes, and providing documentation

Adhere to FDA and GMP regulations

Production

Production planning and scheduling adherence

Batch manufacturing card allocation

Ensure the pilot batches match the standards

Production targets

Ensuring execution and inspection/ testing of incoming and outgoing products conforming to quality conformance

Job allocation to the team as per requirement

Audit of QC processes

Quality audit process to assess quality plan adherence & staff competence

Coordinate with customers or external auditors

Coordinate with departments for implementation of audit requirements

QMS audit as per certifications

Non-compliance investigation and closure

Quality Formulation development

Development of new analytical test/ parameters

Ensuring products as per customer expectations and specifications

Quality Resource Planning

Instruments, manpower and facilities that might be required or to be upgraded

Training

Conducting trainings on process improvements

Compliance

Audit certification compliance

Documentation & reports

Preparation of manuals for specifications and methods of analysis including process control samples for all products and packaging materials, and periodic updating as needed

Maintaining records of all quality audits undertaken

Monitoring records of all quality test undertaken

Monitoring the documents of QC for traceability and completeness as per customer norms and certification guidelines

Prepare Management reports

Prepare documents as per country norms

Maintaining the production records

Customer Complaints

Root cause analysis of customer complaints

Making reports and resolution

Preparation and review of CAPA

Preferred candidate profile

Perks and benefits