Qc Manager

Advy Chemical Pvt. Ltd.; Hyderabad; Sur place; INR 1 800 000 - 2 800 000; Plein temps

Résumé du poste

Advy Chemical Pvt. Ltd. is seeking a senior Quality Control leader to oversee QC operations across raw materials, in-process and finished products, including stability studies.

You will ensure compliance with cGMP, GLP, ISO 13485, and regulatory guidelines, lead a QC team, drive continuous improvement, and coordinate with QA, production and regulatory affairs. Hands-on experience with ISO 13485, GMP/GLP, CAPA, OOS/OOT investigations, and data integrity practices is required, with 9–13 years in

Qualifications

• 9–13 years of Quality Control experience in IVD/Diagnostics/Medical Devices/Life Sciences industries.
• Hands-on QC lab operations across raw materials, in-process, finished products and stability testing.
• Experience with ISO 13485, GMP/GLP, CAPA, OOS/OOT investigations, deviations, change control, and data integrity.
• Exposure to regulatory audits and inspections with ability to maintain audit readiness.
• Proven team leadership and cross-functional coordination with QA, Manufacturing, R&D and Regulatory Affairs.

Responsabilités

• Oversee QC operations for raw materials, in-process, finished products and stability studies
• Ensure compliance with cGMP, GLP, ISO 13485 and regulatory guidelines
• Manage analytical testing (HPLC, GC, UV, dissolution, etc.)
• Handle QMS activities: CAPA, deviation, OOS/OOT, change control
• Ensure audit readiness and support internal, customer and regulatory audits
• Monitor instrument calibration, validation and qualification
• Oversee stability program (real-time, accelerated, trending, reporting)
• Lead and train QC team; allocate work and ensure timely execution
• Coordinate with QA, production and regulatory teams
• Ensure data integrity (ALCOA+) and proper documentation practices
• Drive continuous improvement in QC processes and compliance systems

Connaissances

Quality control

GMP/GLP

QA coordination

Audit readiness

Data integrity

Team leadership

Formation

Bachelor's degree in Life Sciences

Outils

HPLC

GC

UV

Dissolution testing

Description du poste

Role & responsibilities:

• Oversee QC operations for raw materials, in-process, finished products, and stability studies
• Ensure compliance with cGMP, GLP, ISO 13485, and regulatory guidelines
• Manage and review analytical testing(HPLC, GC, UV, dissolution, etc.)
• Handle QMS activities CAPA, deviation, OOS/OOT, change control
• Ensure audit readinessand support internal, customer, and regulatory audits
• Monitor and maintain instrument calibration, validation, and qualification
• Oversee stability program(real-time, accelerated, trending, reporting)
• Lead and train QC team; allocate work and ensure timely execution
• Coordinate with QA, production, and regulatory teamsfor smooth operations
• Ensure data integrity (ALCOA+)and proper documentation practices
• Drive continuous improvementin QC processes and compliance systems

Preferred candidate profile

• 9-13 Years of experience in Quality Control experience in IVD, Diagnostics, Medical Devices, Biotechnology, or Life Sciences industries.
• Good experience in QC laboratory operations, including raw material, in-process, finished product, and stability testing.
• Hands-on experience with ISO 13485, GMP/GLP, CAPA, OOS/OOT investigations, deviations, change control, and data integrity
• Exposure to regulatory audits and inspections, with the ability to maintain audit readiness and ensure compliance.
• Proven team leadership and cross-functional coordination experience, managing QC teams and collaborating with QA, Manufacturing, R&D, and Regulatory Affairs.