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Educational and Experience Requirements:
Education:Bachelor's degree in pharmacy (B Pharm) or Chemical Engineering.
Graduated from a reputed university or college, such as NITs, RECs, or Tier-1 state colleges.
Experience:3 to 7 years of experience in manufacturing or production.
Mixing and Filling OperationsExpert in liquid-liquid and solid-liquid mixing and filling processes.
Proficient in packaging operations with a focus on accuracy, hygiene, and efficiency.
Regulatory ComplianceImplement and oversee manufacturing practices in strict adherence to FDA, WHO, and cGMP guidelines.
Ensure processes meet global quality and safety standards.
Project ManagementSuccessfully managed projects aimed at cycle time reduction, productivity improvements, and line balancing.
Demonstrated ability to drive cross-functional teams towards project milestones and KPIs.
Safety & Risk AnalysisConduct Pre-Startup Safety Reviews (PSI), HAZOP, and Process Hazard Analysis (PHA) for new product introductions.
Lead all Process Hazard Management activities for existing products to ensure safe and reliable operations.
Process Analysis & OptimizationPerform process capability studies, What-if analyses, and variability studies to optimize performance.
Define and refine key process parameters such as cycle time, lead time, takt time, and line balancing.
Process & Equipment QualificationLead and support process qualifications, change control, and IQ/OQ (Installation & Operational Qualification).
Accountable for equipment calibration and maintaining validation records.
Operational ExcellenceFoster shop floor discipline, team engagement, and a culture of 5S, system adherence, and compliance.
Drive continuous improvement through SPC (Statistical Process Control) and process mapping.
Documentation & TrainingManage production reporting and ensure all process documentation is up to date.
Conduct training programs for team members on SOPs and best practices.
Customer-Centric Quality ManagementConduct root cause analyses for customer complaints and deviations.
Implement Corrective and Preventive Actions (CAPA) to drive continuous quality improvements.
Operational ManagementMonitor and maintain line flow, output, and process control for optimal production efficiency.
Capacity Planning & Resource ManagementDevelop and execute capacity plans, shift planning, material issuance, and manpower loading.
Use SAP applications (preferred) for planning, tracking, and analysis.
Improvement InitiativesSpearhead yield improvement, OEE (Overall Equipment Effectiveness), and automation projects.
Apply Industrial Engineering techniques like cycle time, method, and work studies to improve productivity, quality, and safety.
Process Redesign & Layout OptimizationIdentify opportunities and implement process redesigns, layout modifications, and workflow enhancements to boost efficiency and reduce waste.
1. CertificationsSix Sigma Green Belt certification is preferred (not mandatory).
2. Regulatory & Industry ComplianceProven experience working with FDA, WHO, and cGMP standards.
Sound understanding of ICH and WHO guidelines related to pharmaceutical manufacturing and quality systems.
3. Technical ProficiencyHands-on experience in commissioning and qualification processes (IQ, OQ, PQ).
Familiarity with validation protocols and regulatory documentation.
4. Industry ExposureDemonstrated exposure to the pharmaceutical and healthcare industries, preferably in manufacturing or process engineering roles.
5. Corporate ExperienceExperience working in multinational corporations (MNCs) is preferred.
Ability to work within structured environments and adhere to global corporate policies.
6. Career StabilityShows a stable career progression with limited job-hopping.
Preference for candidates with long-term tenures in previous roles, reflecting reliability and commitment.
Learn more about 3M's creative solutions to the world's problems at www.3M.com or on Instagram, Facebook, and LinkedIn @3M.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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