Job Description

Department Details

Role Summary

Identification and raising deviation, change control and compiling other cGMP related documents in coordination with QA
Responsible for preparation, review, and revision of SOP, EOP and batch records.
Responsible to maintain two-way communication with superior and escalate on timely basis for any hindrances / obstacles face during execution of day to day task.
Responsible for updating SOP and EOP master index, organogram, logbook registration list etc.
Responsible for reporting any incident, accident and immediately to the superior.
Adherence to safety, health, hygiene, and environment measures.
Complies with proper, accurate and timely documentation (e.g., logbooks and other relevant work specific documents).
Adherence to cGMP and pharmaceutical guideline.
Support compliance team and coordinate with CFT for QMS element closure; deviation, change control and compiling other cGMP related documents in coordination with QA.
Support compliance team and coordinate with CFT for QMS element closure; deviation, change control and compiling other cGMP related documents in coordination with QA.
Strictly adhere to the EHS, cGMP and defined standard operating procedures and other practices.
Responsible in handling quality documentation of PDP related, such as deviation, change control, OOS, CAPA, SOP.
Ensure all personal training programs and records are up to date as per training matrix.
Responsible to maintain two-way communication with superior and escalate on timely basis for any hindrances / obstacles face during execution of day to day task.

Secondary responsibilities

1)To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable

2) Employees who are involved in GMP activities should undergo a mandatory cGMP training.

3) Frequency of mandatory basic training is once in a year

4) All employees that involving with GxP environment should undergo a mandatory basic microbiology training

5) To provides information, guidance, and recommendations to facilitate compliance with DI, GDP in documentation.

6) To ensure that all documentation is accurate, timely, legible, complete, and permanent (ALCOA principle).

Key Responsibilities

Identification and raising deviation, change control and compiling other cGMP related documents in coordination with QA
Responsible for preparation, review, and revision of SOP, EOP and batch records.
Responsible to maintain two-way communication with superior and escalate on timely basis for any hindrances / obstacles face during execution of day to day task.
Responsible for updating SOP and EOP master index, organogram, logbook registration list etc.
Responsible for reporting any incident, accident and immediately to the superior.
Adherence to safety, health, hygiene, and environment measures.
Complies with proper, accurate and timely documentation (e.g., logbooks and other relevant work specific documents).
Adherence to cGMP and pharmaceutical guideline.
Support compliance team and coordinate with CFT for QMS element closure; deviation, change control and compiling other cGMP related documents in coordination with QA.
Support compliance team and coordinate with CFT for QMS element closure; deviation, change control and compiling other cGMP related documents in coordination with QA.
Strictly adhere to the EHS, cGMP and defined standard operating procedures and other practices.
Responsible in handling quality documentation of PDP related, such as deviation, change control, OOS, CAPA, SOP.
Ensure all personal training programs and records are up to date as per training matrix.
Responsible to maintain two-way communication with superior and escalate on timely basis for any hindrances / obstacles face during execution of day to day task.

Secondary responsibilities

1)To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable

2) Employees who are involved in GMP activities should undergo a mandatory cGMP training.

3) Frequency of mandatory basic training is once in a year

4) All employees that involving with GxP environment should undergo a mandatory basic microbiology training

5) To provides information, guidance, and recommendations to facilitate compliance with DI, GDP in documentation.

6) To ensure that all documentation is accurate, timely, legible, complete, and permanent (ALCOA principle).

Educational Qualifications

Required Education Qualification: BE/ B.Tech - Other
Required Experience: 10 - 15 years

Biocon