Quality Control Manager
10 hours ago
Role Overview:
Lead the Quality Control function for pharmaceutical manufacturing, ensuring analytical accuracy, regulatory compliance, and timely product release. Manage the QC laboratory, develop QC strategy, and act as a technical authority during audits and regulatory inspections.
Key Responsibilities:
•
Lead and manage
the QC department including Analysts, microbiologists, and lab technicians.
•
Oversee analytical testing
for raw materials, in-process samples, finished products, and stability studies.
•
Approve release decisions
for batches in accordance with specifications and SOPs.
•
Maintain compliance
with cGMP/cGLP, PIC/S guidelines and local regulatory requirements.
•
Develop and implement
QC SOPs, test methods, and validation programs. Support best practices in Laboratory in terms of integrity, accuracy and adequacy of the testing and documentation.
•
Manage laboratory quality systems
: deviation handling, CAPA, change control, OOS/OOT investigations, and documentation control.
•
Coordinate regulatory inspections
and supplier audits; prepare QC for site visits and responses.
•
Drive continuous improvement
in test turnaround time, cost control, and method robustness.
•
Budgeting and resource planning
for QC equipment, consumables, calibration, and maintenance.
•
Train and mentor
QC staff; cultivate technical competence and Quality culture.
•
Technology Transfer
: Co-ordination w.r.t Analytical Method Transfer for technology transfer during new product launches.
•
Pharmacopoeia Compliance
: Pharmacopoeia review of specifications and STP's and ensure the compliance.
• Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle.
Qualifications:
•
Bachelor or Master Degree
in Pharmacy, Chemistry, Pharmaceutical Science, or related discipline.
•
At least 15 years'
experience in pharmaceutical QC laboratories, with a minimum of 5 years in managerial role.
•
Strong knowledge
of GMP/GLP, stability testing, analytical techniques (HPLC, GC, UV, titration), and microbiology testing.
•
Demonstrable experience
handling OOS/OOT, method validation/transfer, and regulatory inspections.
•
Excellent leadership, communication, and problem-solving
skills.
• Proficient in
laboratory information systems
.
• Proficiency in Power point presentations.
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