Overview
Quality Control Lead Jobs in Ahmedabad, India at Intas Pharmaceuticals
Job Summary:
The incumbent will be responsible for overseeing and managing the
Quality Control
operations for formulation Manufacturing sites. The incumbent will ensure compliance with global regulatory standards (USFDA, MHRA, EU GMP, TGA, etc.), lead analytical strategies, and drive continuous improvements in QC functions.
Key Responsibilities:
Provide
strategic leadership
and direction to the
Quality Control
function, ensuring robust analytical
quality control
systems for formulations. Oversee QC activities, including raw material, in-process, finished product, stability, and microbiological testing. Ensure compliance with international regulatory requirements and GMP guidelines, addressing regulatory audits and customer inspections. Develop and implement laboratory best practices, automation, and digitization for efficiency improvements. Drive analytical method validation, transfer, and troubleshooting to support product development and commercial manufacturing.
Collaborate with
cross-functional teams
, including
Quality Assurance
, R&D, Regulatory Affairs, and Manufacturing, to ensure seamless quality operations. Lead, mentor, and develop a high-performing QC team with a
focus on innovation
, compliance, and operational excellence. Review and approve critical analytical data, OOS/OOT investigations, deviations, and CAPAs. Spearhead
continuous improvement
initiatives, adopting advanced analytical technologies and risk-based approaches. Monitor emerging regulations and industry trends to proactively adapt QC strategies.
Qualifications &
Experience:
Ph.D./M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or related field. 18+ years of experience in
Quality Control
within the pharmaceutical industry Extensive experience in formulation (oral solids, injectables, ophthalmic, or other dosage forms)
quality control
, with strong expertise in analytical testing and
regulatory compliance
. In-depth knowledge of global regulatory guidelines (USFDA, MHRA, EU GMP, WHO, TGA, etc.).
Proven track record
of managing complex QC operations, audits, and regulatory inspections.
Strong
leadership
, decision-making, and
problem-solving skills
. Excellent
communication
and stakeholder management abilities.
Preferred Skills:
Expertise in advanced analytical techniques (HPLC, GC, LC-MS, etc.). Experience in implementing laboratory automation and
digital transformation
. Lean Six Sigma or Quality Risk Management (QRM) knowledge is a plus.
Title: Quality Control Lead
Company: Intas Pharmaceuticals
Location: Ahmedabad, India
Category: Quality Assurance – QA/QC, Healthcare
