13 Aug
|
TalentXplore
|
India
13 Aug
TalentXplore
India
Department: Quality Assurance / Quality Control
The Quality Manager will be responsible for ensuring compliance,
quality control, and regulatory adherence at third-party manufacturing
facilities. This role involves auditing and monitoring third-party
manufacturers, ensuring GMP compliance, product quality, and regulatory
standards are met while working closely with production, regulatory, and
supply chain teams. The ideal candidate should have a robust production
background with expertise in quality assurance and control.
Key Responsibilities:
Quality Oversight of 3rd Party Manufacturers
Monitor quality standards at
third-party manufacturing facilities.
Conduct regular site visits, audits,
and inspections to ensure compliance with cGMP, WHO-GMP, USFDA,
MHRA, and other regulatory guidelines.
Review and approve batch manufacturing
records (BMRs) and batch packaging records (BPRs).
Compliance & Regulatory Audits
Ensure third-party manufacturers
adhere to quality agreements, SOPs, and regulatory requirements.
Coordinate with regulatory teams for
dossier submissions, product registrations, and regulatory inspections.
Manage deviations, OOS (Out of
Specification), OOT (Out of Trend), and CAPA (Corrective and Preventive
Actions) at third-party sites.
Quality Control & Product Testing
Ensure raw material, in-process, and
finished product testing is conducted as per standard specifications.
Review stability studies, analytical
data, and lab investigation reports.
Collaborate with analytical labs and
QC teams to ensure product quality compliance.
Vendor Qualification & Process Validation
Conduct vendor qualification, supplier
audits, and performance evaluations.
Review and approve process validation,
cleaning validation, and analytical method validation reports.
Work with third-party manufacturers to
optimize processes and improve product quality.
Documentation & Reporting
Maintain quality agreements, technical
agreements, and a
📌 Quality Manager – 3rd Party Manufacturing Panchkula (India)
🏢 TalentXplore
📍 India