QC Manager (API Plant)

BookMyMentor

India

On-site

INR 400,000 - 600,000

Full time

14 days+

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Job summary

BookMyMentor is seeking an Entry Level Quality Control (QC) Manager for their API manufacturing operations in India. The role requires managing end-to-end QC lab operations, ensuring compliance with cGMP and regulatory guidelines, and leading various QC-related projects.

The ideal candidate should have proven experience in QC, especially in API/bulk drug manufacturing, skills in Caliber LIMS, and excellent leadership capabilities.

Qualifications

Proven experience in QC for API / bulk drug manufacturing.
Hands‑on experience with Caliber LIMS.
Strong exposure to QC lab instruments & analytical techniques.
Experience in handling regulatory audits.
Good leadership and team management skills.

Responsibilities

Manage end-to-end QC lab operations in an API plant.
Ensure compliance with cGMP and regulatory guidelines.
Lead QC-related projects and continuous improvement initiatives.
Oversee documentation, stability studies, and analytical activities.
Manage audits, inspections, and regulatory queries.

Skills

Quality Control (QC) for API manufacturing

Caliber LIMS

QC lab instruments

Regulatory audits

Leadership

Job description

Entry Level (0-2 years)

Skilled Quality Control (QC) Manager with strong experience in API manufacturing and QC laboratory operations. Manage end-to-end QC lab operations in an API plant. Ensure compliance with cGMP, regulatory guidelines (USFDA, MHRA, etc.). Handle Caliber LIMS for data integrity and lab management. Lead QC-related projects and continuous improvement initiatives. Oversee documentation, stability studies, and analytical activities. Manage audits, inspections, and regulatory queries. Lead and develop the QC team.

Requirements