To exercise effective control over the environmental conditions in process areas activities, which may affect the product quality.
Compliance to Quality Management System as per cGMP and regulatory requirements at all levels of Manufacturing.
CAPA implementation for observed non-conformance/exceptions.
Training and evaluation of the Production Technicians, Production Associates and Trainee Production Associates for their qualification to specific task or to operate specific equipment.
Preparation of Standard Operating Procedures for production equipments.
Co-ordination for installation and Qualification of Production equipment with Engg., QA and other departments.
To co-ordinate for calibration / preventive maintenance for all production equipments and instruments with Engineering / QA / QC & outside agencies.
To carry out routine documentation as per Regulatory Requirements and to complete BMR/ BPR, Formats & related documents online and timely with all respects.
Coordination with production Planning department for Process Order and Batch Records document with QA.
Organizing the job responsibilities to the Technicians/ITI's as per daily plan and execute the defined targets as per standard outputs. Checking of dispensed input materials against process orders and co-ordination with Warehouse Deptt.
Continuous monitoring of In-process controls in the production areas.
Continuous monitoring and improving the production output on daily basis and control on absenteeism of Technicians/ITI's.
Flexible to work in shifts and would mainly be responsible for Process areas.
To ensure proper maintenance of Production Area and equipments in the state of cleanliness as per the SOPs at all points of time and its upkeep.
To ensure all time readiness for audits.
Have basic knowledge of QMS system, production equipment qualification.