QA Officer / Sr. Officer

Ipca; Wardha; On-site; INR 600,000 - 900,000; Full time

Job summary

Ipca in Maharashtra, Wardha is seeking a QA/Process Validation professional to drive GMP-compliant validation activities. You will prepare and review validation protocols and reports, and ensure master batch production records are accurate and complete.

You will initiate and review change controls, deviation investigations, and SOPs, while ensuring ALCOA++ documentation practices and supplier qualification activities align with established procedures.

Qualifications

• Experience in GMP/QA validation and regulatory expectations.
• Strong knowledge of validation lifecycle and documentation.
• Familiarity with change control and deviation processes in pharma.

Responsibilities

• Prepare/review process validation protocols and reports.
• Review Master Batch Production and control reports.
• Initiate and review change control proposals.
• Initiate and review deviation investigations.
• Prepare and review SOPs for QA and manufacturing.
• Ensure vendor/supplier qualification per procedure.
• Follow ALCOA++ documentation practices and ensure compliance.
• Review rounds and ensure adherence to established procedures.
• Track responsiveness of quality alerts.

Skills

Process validation

Documentation (ALCOA++)

Change Control

Deviation investigations

SOP development

Vendor qualification

GxP compliance

Quality systems

CAPA handling

Job description

Role & responsibilities

1. To prepare/ review process validation protocols and reports.

2. review of the Master Batch Production and control reports.

3. To Initiate and Review change Control Proposals.

4. To Initiate and review deviation investigations.

5. To prepare and review SOP.

6. To ensure vendor/ supplier qualification as per procedure.

7. To follow and ensure the implementation of Good Documentation practices (ALCOA++).

8. To review round and ensure compliance as per established procedures.

9.To track the response of quality alert.