Officer Quality Assurance

Abbott; Solan; On-site; INR 300,000 - 500,000; Full time

Job summary

Abbott in India (Mauza: Baddi region) is seeking an IPQA/Operations Quality professional to ensure GMP and GDP compliance across the Oral dosage facility. The role involves line clearance, in-process checks, sample management, batch documentation, IPQA SOP adherence, instrument calibration, and participation in investigations.

This position requires daily on-site work with standard shifts and exposure to continuous standing.

Qualifications

• Compliance with current Good Manufacturing Practices in the Oral dosage facility.
• Data-integrity compliance with GDP as applicable.
• Good Manufacturing Practices and GDP adherence in manufacturing and packing.

Responsibilities

• Carry out line clearance and in-process checks at various stages of batch manufacturing and packing.
• Collect and manage control samples, stability samples, validation samples and maintain records.
• Issue batch records and review executed batch documents.
• Issue controlled copies of logbooks and formats.
• Ensure IPQA SOPs and records are followed and calibrate IPQA instruments.
• Assist investigation activities as needed.
• Provide SOP training in ISOtrain or via self-training within the stipulated time.
• Follow all safety practices and COBC.

Job description

JOB DESCRIPTION:

Followings will be the responsibilities of the position holder:

1. Compliance of current Good Manufacturing Practices in the Oral dosage facility & to follow GDP with data-integrity compliance.

2. Manufacturing and Packing process compliance in accordance with approved BMR/BPR.

3. To carry out line clearance, In-process checks at the different stages of batch manufacturing and packing.

4. Collection and management of control samples / stability samples / validation samples / other samples (as applicable) and maintain their record.

5. Issuance of Batch records and review of executed batch documents.

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6. Issuance of controlled copies of Logbooks and formats.

7. Compliance of IPQA related SOPs and records.

8. Calibration of IPQA instruments and to maintain related records.

9. To assist investigation activities.

10. SOP training in ISOtrain of self-train within stipulated time.

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11. To follow all the practices related to safety and COBC.

In absence of the position holder, designated Executive-IPQA shall be authorized designee and responsible for day to day working.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

India > Village Mauza : Baddi

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)