Quality Assurance Officer - Pharmaceutical Manufacturing

Abbott India Ltd; Solan; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Abbott India Ltd. seeks an Officer Quality Assurance to ensure GMP/GDP compliance in the Oral dosage facility at Village Mauza: Baddi, India. The role covers batch review, sample management, IPQA activities, investigations, and training, with a focus on compliance and safety.

The position is senior-level within Operations Quality, based at the site in India. The company offers a challenging, hands-on role in established pharma operations.

Responsibilities

• Comply with current Good Manufacturing Practices in the Oral dosage facility and GDP with data-integrity compliance.
• Manufacturing and Packing process compliance according to approved BMR/BPR.
• Carry out line clearance and in-process checks at different 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 compliance.
• Calibrate IPQA instruments and maintain related records.
• Assist investigation activities.
• Provide SOP training in ISOtrain or self-training within stipulated time.
• Follow safety and COBC practices.

Job description

Officer Quality Assurance 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. 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)

Experience Level Senior Level