Assistant Manager

3 weeks ago

Dahej, India Milan Laboratories Full time

Key Responsibilities:

  • Oversee daily QA operations in SVP manufacturing and ensure compliance with cGMP and regulatory guidelines.
  • Perform and supervise IPQA activities in production areas including line clearance, in-process checks, aseptic practices, and documentation verification.
  • Review and approve batch manufacturing records, quality control data, deviations, change controls, and CAPAs.
  • Ensure timely investigation and closure of deviations, incidents, and OOS results.
  • Monitor and review environmental monitoring and microbiological trends, ensuring compliance with aseptic standards.
  • Actively participate in media fill and aseptic process validation oversight.
  • Participate in internal audits, vendor audits, and regulatory inspections; coordinate responses and CAPA implementation.
  • Ensure preparation, review, and approval of SOPs, protocols, and reports related to SVP manufacturing, IPQA, and quality systems.
  • Provide training to production and QC personnel on GMP, GDP, aseptic behavior, and regulatory requirements.
  • Support validation activities (process, cleaning, sterilization, and equipment qualification) by ensuring documentation and compliance.
  • Drive continuous improvement initiatives to strengthen product quality and system robustness.

Key Skills & Competencies:

  • Strong knowledge of sterile/SVP manufacturing and hands-on IPQA activities.
  • Sound understanding of QMS elements (deviation, CAPA, change control, risk management).
  • Good analytical, problem-solving, and decision-making skills.
  • Strong communication and leadership skills to manage cross-functional teams.
  • Exposure to regulatory audits (USFDA, MHRA, EU, WHO, etc.) preferred.

Interested candidate can share resume on

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