Training of employees
Every employee of the organisation shall first undergo an Induction Training and then to be trained on his / her area of operation prior to start the work. Induction Training shall also include a visit and understanding of works done in Departments other than their own. An Induction Training Record shall be maintained for the new employee as per the Annexure, Orientation & Induction training record. The training shall be imparted depending on the nature of job and responsibilities and the cGMP training is mandatory for each employee.
- Training Plan
- The training needs shall be based on the criticality of the operation performed by the employees working in different areas.
- Departmental HOD shall identify the need of training for different levels. The training need identification shall be primarily based on technical aspect related to the operational area.
- One week prior to execution of training, Quality Assurance (responsible for Training) shall circulate a reminder to concerned HOD, so that they can plan accordingly the activities of their employees. Concerned department shall confirm the date of training and shall inform to concern HOD about the date and time of training session.
- All the respective department training record shall be maintained by HR dept.
- induction Training should include cGMP / GLP / GEP / GDP
- also on Job training /Safety Training/Need base/Refreshing training should be given to personnel
- Training should be given by level vise as pen there assigned duties.
- Also Training of Regulatory guidelines has to given.
- Selection of Trainer
- Internal trainer from different departments shall be identified based on his / her qualification, communication / presentation skills, experience, knowledge and expertise or combination of thereof in the different areas of operation.
- QA shall prepare list of internal trainers, which shall be approved by Head – Quality Assurance The list shall be updated as and when required.
- Prior to start of the training the participants shall fill their attendance for all types of training .
- On the Job Training
- On the job training shall include the training in the concerned and cross functional departments of the new employees and other as identified.
- On the job training shall be imparted to all the new joiner’s as well as to existing employees by the concerned HOD or his / her designee related to the area of operation. This training program shall include the training related to the specific aspects of an individual’s role including use of equipment, unit operations, safety norms to be followed and adherence to cGMP.
- The mode of imparting training shall be through SOP’s, Cleaning Procedures, Operating Instructions, Preventive Maintenance Procedures and Practical Assessment wherever possible.
The documentation of different types of training shall be done by the departments as mentioned below:
- Induction Training : HR / QA
- On the Job Training : Concerned Department
- Technical Training : Concerned Department
- For EU Training : EuDraLex VL- 4
- Representative from respective department shall coordinate with QA dept. for conducting any training and maintaining the record of the same.
- Staff Training card of each employee shall be maintained by QA department.
- all personnel should have training records updated.
- QA personnel should randomly verify the training records during the Internal audit of the departments.