Assistant Manager - QA SVP

Milan Laboratories

12 - 14 years

9 - 11 Lacs

dahej

Posted:1 day ago| Platform:

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Skills Required

ipqa documentation sterile injectables quality assurance

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 dipika.parmar@milanlabs.com

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