Senior Executive - Production (lyophilization)

Fact Personnel

4 - 7 years

4 - 7 Lacs

ahmedabad

Posted:None| Platform:

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Skills Required

parenteral lyophilization regulatory audits compliance sterile injection

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Operate and manage
freeze drying and lyophilization equipment
, including Freeze Dryer, Palltronic Integrity Tester, and CLU.
Ensure smooth functioning of
computerized systems
such as
eBMR, PLC, SCADA
, and manage data integrity, audit trails, and system backups.
Participate in
equipment and area qualification/requalification
activities, including
LAF (Laminar Air Flow)
systems.
Ensure adherence to and documentation of
Change Controls
,
Risk Assessments (RA)
,
Corrective and Preventive Actions (CAPA)
, and
EHS (Environment, Health, and Safety)
protocols.
Ensure compliance with regulatory standards and assist during
audits and inspections
.
Maintain accurate and timely documentation as per
GMP
guidelines.

Preferred candidate profile

Bachelors degree in Pharmacy (B. Pharma)
– Mandatory
4 to 7 years of experience in a
sterile pharmaceutical manufacturing environment
, specifically in
Lyophilizer operations
.
Strong understanding of
pharmaceutical regulatory standards
, including GMP, FDA, MHRA, etc.
Familiarity with
automation and computerized systems
like eBMR, SCADA, PLC.
Sound knowledge of
qualification protocols
,
equipment handling
, and
process controls
.
Excellent documentation and communication skills.
Proactive, team-oriented mindset with the ability to handle audits and cross-functional coordination.

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