Biological E - Manager/Sr Manager - cGMP Trainer

Academic Background and Experience

M.Pharm/M.Sc/Any PG

8-15 years of experience, Experience in Pharmaceuticals & Biotech Industries.

Adequate exposure on cGMP, Out of total experience from QA/QC at least 2-3 years- experience in training is must.

Purpose: To Drive process and strengthening the manufacturing practices as per the regulatory guidelines.

Job responsibilities

- Should have an inclination towards SOP and GMP Compliance.

- Responsible to evaluate training requirements (technical) as per regulatory guidelines.

- Ensure the preparation of departmental training calendar & employee training need identification

- Identity & build the team of in-house trainer to optimize training cost.

- Ensure the execution of training as per Calendar with the help of team of internal / external trainer

- Responsible to impart the training on GMP / Regulatory Guidelines.

- Responsible for evaluating training effectiveness.

- Responsible to maintain training software for tracking the compliance/non-compliance of execution of training v/s training calendar

- Responsible to maintain the documentation of training like Training SOP, Employee Training files, Training Manuals.

Operating Network

Internal: All cross functional heads of operations

External: Auditors, trainers

Technical Requirements: Having working knowledge on Track wise application, technical training of personnel's at WHO approved plants

Key personal competencies:

Strong verbal & written communication skills, networking skills, team management