Lead - Microbiologist, ACG Capsules, Pithampur

Role & responsibilities

1 Learn and follow cGMP compliance

2 Micro Department functioning- Routine and monitoring

3 Learn & Monitor of Micro Load in Environament & Product

4 BMR Review, Batch Investigation based on BMR findings with respect to Micro Failures

5 Learn & Monitor HVAC & Water System with respect to Micro Failures 6 Learn, Plan, Allocate, Review of RM Analysis & Release

7 Customer Complaint Analysis, RCA, CAPA Implementation & Follow up compliances for micro Complaints

8 Understanding product and process- Micro point of view

9 Learn and follow QMS system compliance

10 Monitor, analyse and review in Process quality control checks - Basic 11 Monitor, Analyse and review of manufacturing process from Micro Point of view

12 Automation, Digitization & OpEx Projects from Micro Point of view

13 Learn and carry out Q&V of various equipment - Basic

Primary responsibilities

1 Microbial activities of RM, FP & Inprocess

2 Critical SOP Complainces

3 Control of Microbiological failures.

4 Implementation of Novel Microbiogical test.

5 IQC Activities

6 Customer Complanits

7 Monitor & analyze IQC activities

8 OpEx, Automation & Digitization Projects

9 QMS and Q&V of New Projects

CORE responsibilities

1 Microbial Activities

2 Implementation of new Microbiological practices.

3 Training and wareness to the team for control of Microbiological failures.

4 Complaint handling / Detail investigation

5 SOP Compliance