QA Senior Executive

2 weeks ago

New Town Kolkata West Bengal, India A. N. Pharmacia Pvt. Ltd., Kolkata 700136 Full time ₹ 3,60,000 - ₹ 43,20,000 per year

Monitoring and Inspection:

  • Real-time Process Monitoring: Observing all stages of production (dispensing, granulation, compression, coating, filling, packaging, etc.) to ensure strict adherence to documented Standard Operating Procedures (SOPs) and GMP guidelines.
  • Line Clearance Activities: Performing thorough checks and providing approval (line clearance) before the start of any new product, batch, or process changeover to prevent mix-ups and cross-contamination.
  • In-Process Checks (IPC): Conducting or verifying in-process quality control tests and parameters, such as tablet weight variation, hardness, friability, disintegration time, pH, and viscosity, as specified in the Batch Manufacturing Record (BMR).
  • Environmental Monitoring: Monitoring and documenting critical environmental conditions like temperature, humidity, and differential pressure in cleanroom and manufacturing areas.
  • Process Validation: During process validation providing documented evidence that, manufacturing process consistently yields a product of predetermined quality.
  • Equipment Status Verification: Ensuring that all equipment, instruments, and systems are properly calibrated, validated, and have the correct "clean" or "in use" status labels.

Documentation and Compliance:

  • Batch Record Review: Reviewing and verifying Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) in real-time or after completion to ensure all entries are accurate, complete, and signed off as per GMP requirements.
  • SOP Management: Controlling the issuance, retrieval, and adherence to SOPs, BMRs, and other quality documentation.
  • Deviation and Non-Conformity Handling: Identifying, reporting, and documenting any deviations or non-conformities from approved procedures. They often assist in the investigation (root cause analysis) and the implementation of Corrective and Preventive Actions (CAPA).
  • Audit Readiness: Ensuring that their assigned production areas are continuously compliant and ready for internal audits, self-inspections, and external regulatory inspections (e.g., WHO, ISO).

Collaboration and Training:

  • Cross-functional Collaboration: Working closely with the Production, Quality Control (QC), and Research and Development (R&D) teams to resolve quality issues and promote continuous improvement initiatives.
  • Training Staff: Training and mentoring production and packaging staff on quality procedures, GMP, and data integrity practices.

Job Types: Full-time, Permanent

Pay: ₹30, ₹34,785.39 per month

Benefits:

  • Leave encashment
  • Paid sick time
  • Provident Fund

Application Question(s):

  • What is your highest Qualification?

Education:

  • Bachelor's (Preferred)

Experience:

  • Tablet manufacturing: 5 years (Required)

Language:

  • Bengali, Hindi & English (Preferred)

License/Certification:

  • CTS for Pharmaceutical Production (Required)

Location:

  • New Town, Kolkata, West Bengal (Preferred)

Shift availability:

  • Day Shift (Preferred)

Work Location: In person

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