15 - 20 years
0 Lacs
Posted:1 month ago|
Platform:
On-site
Full Time
Job Purpose:
To lead and oversee all API manufacturing operations ensuring compliance with cGMP, safety, quality, productivity, and cost-effectiveness, while maintaining a culture of continuous improvement.
Plan, coordinate and execute API manufacturing activities in line with production schedules and business targets.
Ensure optimum utilization of plant capacity, manpower, and resources.Monitor key production KPIs and take corrective/preventive actions as necessary.
Ensure strict compliance with cGMP, ICH, regulatory guidelines, and internal quality standards.
Coordinate with QA/QC, Regulatory Affairs, and EHS departments to maintain inspection readiness (USFDA, WHO, EDQM, etc.).Support quality investigations (deviations, OOS, change control, CAPA) related to production activities.
Drive a strong safety culture by ensuring adherence to all EHS standards.
Lead risk assessments (HAZOP, JSA) and support implementation of safety recommendations.
Lead, develop and mentor a team of production professionals, operators, and shift in-charges.
Promote cross-functional collaboration, performance management, and employee engagement.
Initiate and implement process improvement initiatives (Lean, Six Sigma, OEE improvement).
Collaborate with Engineering, Projects, and Technology Transfer teams for new product introductions and capacity expansions.
Ensure timely and accurate documentation of batch records, logbooks, equipment cleaning records, and SAP entries as per GMP requirements.
Desired Candidate Profile:
Qualifications:
B.E./B.Tech in Chemical Engineering or M.Sc. in Chemistry
Additional certifications in GMP/Lean/Six Sigma will be an added advantage
15 - 20 years of experience in API Manufacturing
At least 5-10 years in a leadership role handling large-scale production unitsHands-on experience with regulatory audits (USFDA, EU, etc.)Skills & Competencies:
Strong technical knowledge of API manufacturing processes (solvents, reactors, crystallization, etc.)Proven leadership and people management capabilitiesGood understanding of GMP, EHS, and SAP systemsStrong analytical, communication, and decision-making skills
FTJ Consultants
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