07 Aug
|
Fare Labs
|
Gurugram
07 Aug
Fare Labs
Gurugram
Role & responsibilities
Designation: Incharge (Drugs & Pharma, AYUSH Section)
Qualification: Ph.D./M.Sc. Chemistry
a) Overall responsible for planning, supervision and management of Drugs & Pharmaceuticals and AYUSH laboratory activities in compliance with ISO/IEC 17025:2017, NABL requirements and applicable regulatory guidelines.
b) Must have experience in handling NABL assessments and regulatory audits related to Drugs & Pharmaceuticals and AYUSH departments.
c) Must have exposure to testing requirements and quality systems of national and multinational companies for Drugs & Pharmaceuticals and AYUSH products.
d) Authorized to allocate test samples to technical personnel based on competency and monitor testing activities related to Pharmaceuticals, APIs, Herbal products, AYUSH formulations, Nutraceuticals, raw materials and finished products.
e) Ensure proper method validation/verification, measurement traceability, calibration and maintenance of instruments, equipment and reference standards.
f) Responsible for review and authorization of test reports, statements of conformity, opinion & interpretation and compilation of test results considering regulatory and customer requirements.
g) Ensure effective implementation and maintenance of Quality Management System including document control, record retention, data integrity, internal audits, management review,
risk assessment, CAPA and non-conforming work handling.
h) Monitor and ensure satisfactory participation in proficiency testing (PT), inter laboratory comparison (ILC), internal quality checks and other quality assurance activities.
i) Responsible for maintaining integrity of analytical results, raw data calculations, logbooks, records and laboratory documentation.
j) Ensure environmental monitoring, laboratory housekeeping, safety practices and proper storage of samples, chemicals and reference standards.
k) Provide technical guidance, troubleshooting support and training to scientists, analysts and laboratory personnel and evaluate staff competency requirements.
l) Coordinate with regulatory authorities, accreditation agencies, auditors and clients regarding laboratory activities and compliance matters.
m) Ensure compliance with AYUSH regulations, Drugs & Cosmetics Act, Pharmacopoeia requirements (IP/BP/USP/Ayurvedic Pharmacopoeia) and NABL guidelines.
n) Responsible for timely reporting and coordination of instrument breakdowns, repairs and maintenance activities.
o) Responsible for preparation and review Standard Testing Procedures (STP), Analytical Method Validation (AMV) protocols, AMV reports, stability study protocols and other technical records.
📌 Lab Incharge(Drugs & Pharma,Ayush Section) (Gurugram)
🏢 Fare Labs
📍 Gurugram