, and packing support.
Operate and monitor equipment such as
RMG, FBD, Multi-mill, Blender, Compression Machines, Coating Pan
.
Ensure batch manufacturing as per
BMR/BPR
and approved SOPs.
Maintain line clearance and follow
cGMP
practices.
FDA / GMP Compliance
Ensure compliance with
USFDA, WHO-GMP, Schedule-M
guidelines.
Handle
FDA audits, regulatory inspections
, and observations.
Prepare and review documentation for
deviations, change controls, CAPA
, and investigations.
Ensure data integrity and good documentation practices (GDP).
Documentation & Records
Prepare, review, and maintain
Batch Manufacturing Records (BMR)
.
Follow SOPs, logbooks, equipment cleaning records, and validation protocols.
Assist in
process validation, cleaning validation
, and qualification activities.
Quality & Safety
Coordinate with
QA/QC
for in-process checks and release activities.
Ensure compliance with safety, hygiene, and EHS standards.
Identify and report process deviations or product quality issues.
Skills & Competencies
Strong knowledge of
tablet dosage form manufacturing
.
Practical exposure to
FDA approved pharma plants
.
Sound understanding of
cGMP, SOPs, GDP, and regulatory documentation
.
Ability to work independently and in a team.
Good communication and problem-solving skills.
Preferred Candidate Profile
Experience in
USFDA approved tablet manufacturing facility
.
Exposure to
regulatory audits and inspections
.
Knowledge of
process optimization and troubleshooting
.
Job Types: Full-time, Permanent
Pay: ?25,000.00 - ?40,000.00 per month
Experience:
production: 5 years (Preferred)
Work Location: In person
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