Executive - Engineering Documentation (API Unit) @Bhiknoor, Kamareddy

MSN Group

2 - 5 years

3 - 5 Lacs

Bhiknoor

Posted:2 months ago| Platform:

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Skills Required

Engineering Documentation Engineering QMS Qualification Documentation AutoCAD Drawing Schedule Preparation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary:

Executive Engineering Documentation

Key Responsibilities:

Prepare, review, and maintain
equipment qualification documents
(IQ/OQ/PQ).
Assist in managing
Change Control procedures
related to equipment and utility modifications.
Prepare and update
logbooks, calibration schedules, preventive maintenance schedules
, and related engineering records.
Verify and maintain documentation for water systems, HVAC, and plant utilities in compliance with cGMP.
Ensure timely
updating and archival of engineering drawings
(P&ID, GA, loop diagrams, etc.).
Coordinate with validation, QA, and maintenance teams for document-related activities.
Maintain compliance of documentation with regulatory expectations (USFDA, WHO, EU GMP, etc.).
Support audit preparedness by ensuring document accuracy, traceability, and timely retrieval.

Required Skills:

Good knowledge of
equipment qualification (IQ/OQ/PQ)
and engineering documentation systems.
Familiarity with
change control management
, document control procedures, and audit readiness.
Proficiency in
MS Office
,
AutoCAD (basic knowledge preferred)
, and documentation tools.
Strong communication, organizational, and record-keeping skills.
Understanding of
pharma utility systems
like water plants, HVAC, and cleanroom equipment.

Preferred Industry Experience:

Pharmaceutical API or Formulations industry (mandatory)

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