(Immediate Start) Assistant Manager

1 day ago

Raichur KA IN Hema Laboratories Full time

Job Title Assistant Manager - R D Production QC QA Industry Pharmaceuticals Intermediates APIs Experience 12 Years Location Insert Location Reporting to Plant Head General Manager Job Summary A seasoned pharmaceutical professional with over 12 years of comprehensive experience in Research Development R D Production Quality Control QC and Quality Assurance QA for intermediates and API manufacturing Responsible for ensuring smooth operation of all plant functions driving innovation and ensuring adherence to quality safety and compliance standards Key Responsibilities 1 Research Development R D Lead development of new intermediates and API processes with focus on yield improvement cost reduction and scalability Implement and validate process optimization strategies Collaborate with analytical R D for method development and validation Conduct feasibility studies and pilot trials for new products 2 Production Plan execute and supervise daily manufacturing activities Monitor batch manufacturing records BMRs and ensure compliance with cGMP Ensure smooth coordination between planning maintenance and production teams Troubleshoot process deviations and resolve operational issues effectively Maintain productivity targets while minimizing downtime and wastage 3 Quality Control QC Supervise QC operations including raw material in-process and finished product testing Ensure timely release of materials with validated analytical methods Monitor stability studies and calibration of analytical instruments HPLC GC etc Review COAs and ensure analytical compliance with regulatory specifications 4 Quality Assurance QA Ensure cGMP GLP and regulatory compliance across departments Handle documentation SOPs BMRs deviations change controls CAPA etc Coordinate internal and external audits regulatory customer ISO etc Conduct training sessions for personnel on quality systems and regulatory expectations 5 Plant Operations Compliance Manage cross-functional teams to ensure smooth operations Maintain EHS Environment Health Safety standards as per statutory norms Participate in technology transfer and scale-up projects Liaise with regulatory agencies for documentation and licensing support Skills Competencies Deep knowledge of API intermediate manufacturing processes Strong understanding of regulatory guidelines ICH USFDA WHO-GMP EUGMP Leadership and team management skills Proficiency in documentation problem-solving and audit handling Familiarity with QMS tools and digital documentation systems Technical Expertise Process chemistry and scale-up cGMP QMS GLP EHS standards Analytical instruments HPLC GC UV IR Documentation SOPs BMR BPR STP COA Regulatory audit preparedness Education B Sc M Sc in Chemistry Organic Chemistry Pharmaceutical Sciences or B Tech M Tech in Chemical Engineering Pharma Technology Job Type Full-time Pay 75 000 00 - 80 000 00 per month Benefits Food provided Health insurance Provident Fund Ability to commute relocate Raichur Karnataka Reliably commute or planning to relocate before starting work Required Education Master s Required Experience Plant management 10 years Preferred Language Telugu english hindi Preferred Location Raichur Karnataka Preferred Shift availability Day Shift Required Work Location In person

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