Job Description

This role involves monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teams

Key Responsibilities

Ensure adherence to

cGMP and GDP practices

during all in-process activities.


Perform

line clearance

checks before starting production and packaging operations.


Monitor and verify

critical manufacturing and packaging parameters

as per approved BMR/BPR.


Review and ensure compliance with

SOPs, protocols, and regulatory guidelines

.


Verify sampling, labeling, and dispensing of raw materials and intermediates.


Perform

in-process checks

and record observations in real-time.


Ensure timely identification, documentation, and escalation of any

deviations, OOS, OOT, or incidents

.


Support QA team in

investigations and CAPA implementation

.


Participate in

internal audits, regulatory inspections, and compliance activities

.


Maintain effective communication with Production, QC, and QA teams for smooth operations.


Ensure that all activities are performed safely and in accordance with company policies.

Skills & Competencies

Strong knowledge of

cGMP, GDP, and regulatory compliance

.


Hands-on experience in

API manufacturing processes

.


Good understanding of QA/QC procedures.

Strong communication and interpersonal skills

for cross-functional coordination.


Documentation accuracy and attention to detail.


Ability to work in a fast-paced manufacturing environment.

Qualification:

M.Sc. (Chemistry/Pharmaceutical Sciences)

Experience:

2 to 4 Years (API industry experience mandatory)

Additional Responsibilities

Conduct periodic

shop floor rounds

to ensure compliance with cGMP and safety practices.


Provide

on-the-job training

to production personnel on documentation and quality practices.


Support preparation and review of

SOPs, protocols, and batch records

.


Monitor and control

environmental conditions

in production areas (temperature, pressure differentials, cleanliness).


Ensure timely

closure of deviations, CAPA, and change controls

related to IPQA activities.


Support

technology transfer and validation activities

from a QA perspective.


Assist in

review of batch manufacturing records (BMR) and batch packaging records (BPR)

for completeness and compliance.


Act as QA representative during

regulatory and customer audits

.


Contribute to

continuous improvement initiatives

in QA and manufacturing processes.