Executive IT (GMP Operations) || (Karakhadi Plant) Vadodara

Alembic Pharmaceuticals

3 - 5 years

3 - 8 Lacs

vadodara

Posted:None| Platform:

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Skills Required

it gmp operations qc systems csv qa it gmp gmp compliance good manufacturing practices mhra computer system validation empower usfda chromeleon 21 cfr part 11 data integrity & security gxp compliance regulatory audit support scada

Work Mode

Work from Office

Job Type

Full Time

Job Description

Executive IT (GMP Operations)

Key Responsibilities:

Oversee
IT GMP operations
for QC and Manufacturing systems.
Manage
user access
,
data security
,
domain controllers
, and
backups
.
Integrate manufacturing equipment with IT systems and ensure
GxP system
compliance.
Administer QC and Manufacturing applications like
Chromeleon, Empower
, etc.
Operate and support
SCADA, HMI
, and other manufacturing systems.
Ensure
IT infrastructure qualification
and
regulatory compliance
.
Implement and configure
Manufacturing/QC GxP systems
.
Maintain
IT SOPs
and ensure compliance during
regulatory audits
(USFDA, etc.).
Communicate effectively and demonstrate
leadership
in cross-functional

Candidate Profile:

Bachelor's in IT, Computer Science, or related field.
35 years in pharma IT within a
GMP environment
.
Strong understanding of
21 CFR Part 11, GAMP 5, Annex 11
, etc.
Experience with
regulatory audits
and IT compliance.
Good problem-solving, communication, and
leadership skills
.

Interested candidates can share their updated resume at

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