Manager

Cadila Pharmaceuticals

10 - 16 years

8 - 13 Lacs

ankleshwar

Posted:-1 days ago| Platform:

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Skills Required

qc uv team handling karl fischer gc hplc api manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position Title:

Key Responsibilities:

Plan and provide
analytical support
as per approved specifications, test procedures, and SOPs.
Ensure all analyses are completed as per
customer specifications and dispatch schedules
, coordinating closely with planning and dispatch teams.
Review and monitor
daily QC activities and dispatch-related analysis
, and report progress to the QC Head.
Approve or reject
raw materials, packing materials, intermediates, and finished products
based on analytical data and established specifications.
Review and approve
Certificates of Analysis (CoA)
for all materials and products prior to release.
Coordinate and plan
joint analytical method transfers
with R&D for HPLC/GC and other analytical techniques.
Review and approve
supplemental specifications
as per customer requirements.
Plan and execute
analyst qualification programs
and provide on-the-job technical training to subordinates.
Ensure
instrument qualification, preventive maintenance, and calibration
are carried out as per approved schedules and records are properly maintained.
Ensure
CFR 21 Part-11 compliance
for computerized systems with proper online documentation and periodic audit trail review.
Conduct and facilitate training programs on
cGMP, GLP, ISO systems, technical skills, and instrumental operation
for all QC personnel.
Act as an
authorized reviewer
for HOD-level review and impact assessment of
Change Controls, CAPA, Deviations, OOS, and OOT
within the LIMS system.
Ensure strict adherence to
GLP, safety, and data integrity
practices in the laboratory.
Drive continual improvement in laboratory practices, documentation quality, and analyst competency.

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