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QA Head

ACME SERVICES PRIVATE LIMITED

14 - 16 years

13 - 17 Lacs

bengaluru

Posted:4 days ago| Platform:

Apply

Skills Required

capa change control process validation qms cleaning validation risk assessment equipment qualification data validation ipqa documentation auditing regulatory compliance packaging gmp quality systems sop quality assurance api finished products

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Quality Systems & Documentation:

Develop, implement, and maintain GMP-compliant QMS.
Oversee change control, deviations, CAPA, incident management, risk assessment,
and market complaints.
Ensure GDP compliance in all QA documentation, including SOPs, batch records,
specifications, and MOAs.
Prepare and revise SOPs, distribute and retrieve old versions, and manage
documentation control.
Handle QMS activities like return goods, non-conformities, and investigation reports
(5-Why, 6M method).

2. Validation & Qualification:

Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports.
Manage process validation, cleaning validation, equipment qualification, and facility
validation.
Conduct IPQA rounds and ensure adherence to in-process checks.

3. Regulatory Compliance & Audits:

Coordinate and face internal, customer, and regulatory audits.
Prepare CAPA reports and ensure timely closure of audit findings.
Provide quality-related data for regulatory filings including DMFs.

4. Training & People Development:

Conduct GMP and QA-related trainings as per monthly/yearly plans.
Evaluate personnel qualification reports and assign qualification numbers.
Promote a culture of continuous improvement and compliance across teams.

5. Material Management & Specification Review:

Qualify vendors through supplier audits and documentation.
Review and approve specifications for finished products, APIs, raw materials,
packaging materials, and TDS.
Monitor stability studies and review summary reports for product shelf life and
storage conditions.

6. Logbooks, Formats & Communication:

Prepare and issue formats, logbooks, and registers.
Handle email communications for quality-related queries and documentation.
Participate in cross-functional assignments and responsibilities delegated by HOD.

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QA Head