Officer Quality Assurance

Abbott; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Abbott in India (Village Mauza: Baddi) is seeking an IPQA professional to ensure GMP compliance in oral dosage operations and to uphold data integrity across the manufacturing process.

You will perform line clearance, sampling, and batch record issuance, while calibrating IPQA instruments and maintaining SOP records. Training via ISOtrain and safety practices are integral to daily tasks.

Qualifications

• Ensures GMP compliance in oral dosage facility and GDP with data integrity.
• Manages sampling and in-process checks at multiple stages of batch manufacturing.
• Coordinates calibration of IPQA instruments and maintains related records.
• Maintains training per ISOtrain within stipulated time.

Responsibilities

• Carry out line clearance and in-process checks across batch stages.
• Collect and manage control, stability, validation samples and records.
• Issue batch records and review executed batch documents.
• Maintain logbooks and formats and ensure control copies are issued.
• Assist investigations as needed.
• Follow safety and COBC practices.

Skills

GMP compliance

Data integrity

IPQA

SOP training

Tools

IPQA instruments

Job description

JOB DESCRIPTION

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. undefined
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. undefined
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
• ADDITIONAL LOCATIONS:
• 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)