AGM - QC Head

Rusan Pharma

15 - 20 years

12 - 20 Lacs

gandhidham

Posted:5 days ago| Platform:

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Skills Required

regulatory compliance management quality control leadership in pharma formulations lab incident & oos/oot investigation product complaints change request management cleaning validation recall handling stability study protocols compliance deviation management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities

Lead, manage, and develop the QC function for pharma formulations as per company policies and regulatory requirements.
Supervise and resolve
lab incidents, deviations, change controls, OOS/OOT
, and ensure robust documentation and root cause analysis.
Oversee
process validation, cleaning validation, hold time studies
and related compliance activities.
Establish and implement
Stability Study protocols
as per company SOPs, client specification, and all applicable quality standards.
Handle
product complaints & recall investigations
in collaboration with QA and Production teams.
Ensure compliance with current
GMP, GLP, and regulatory guidelines
for all laboratory operations.
Maintain rigorous control of QC documentation, data integrity, and quality records.
Coordinate external laboratory audits, regulatory inspections, and support internal audit programs.
Train, mentor, and appraise QC staff for skills development and process improvements.

Desired Candidate Profile

Education:
M.Sc / B.Sc / M.Pharm / B.Pharm (Chemistry/Pharmaceuticals/Relevant field)
Experience:
15-20 years in Quality Control for pharma formulations (regulated plants preferred)
Strong expertise in managing
lab incidents, OOS/OOT, deviation, change control, validation activities, and stability protocols
Well-versed with handling investigations for
product complaints and recalls
Familiar with global quality standards and client requirements
Excellent leadership, team management, and communication skills
Ability to collaborate cross-functionally and drive continuous improvement

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