31 Oct
|
AZENTYX HEALTHCARE
|
Baddi
31 Oct
AZENTYX HEALTHCARE
Baddi
Job Title: IPQA Executive
Department: Quality Assurance (QA)
Experience: 1–3 Years
Qualification: B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. (as per company requirements)
Industry: Pharmaceutical Manufacturing
Location: Barotiwala, Baddi, Himachal Pradesh
Reporting To: IPQA Officer / IPQA Manager / QA Manager
1. Job Purpose
To ensure compliance with established quality standards, Good Manufacturing Practices (GMP), and approved Standard Operating Procedures (SOPs) during pharmaceutical manufacturing and packaging operations.
2. Key Responsibilities
A. In-Process Quality Checks
- Perform routine in-process checks during manufacturing and packaging operations.
- Verify line clearance before starting manufacturing and packaging activities.
- Check product name, batch number, manufacturing date, expiry date, and packaging materials against approved documents.
- Monitor critical process parameters as per approved Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs).
- Ensure compliance with approved specifications and acceptance criteria.
B. Documentation and Batch Records
- Review and verify BMRs and BPRs for completeness and accuracy.
- Ensure entries are made in accordance with Good Documentation Practices (GDP).
- Verify equipment cleaning records, logbooks, and applicable process records.
- Report discrepancies, missing entries, and documentation errors to the concerned QA supervisor.
- Maintain IPQA records as per the document control procedure.
C. GMP and SOP Compliance
- Ensure compliance with cGMP, GDP, and approved SOPs.
- Monitor personnel hygiene, gowning practices, and adherence to area-specific procedures.
- Conduct routine shop-floor inspections to identify GMP deficiencies.
- Ensure proper status labelling of materials, equipment, and manufacturing areas.
- Support implementation of quality systems and data integrity requirements.
D. Deviation, CAPA and Change Control
- Report deviations, incidents, and non-conformities observed during manufacturing or packaging.
- Assist in deviation investigations and root cause analysis.
- Support CAPA implementation and effectiveness verification.
- Report any unauthorized changes or departures from approved procedures.
- Participate in change control activities as assigned.
E. Equipment and Area Verification
- Verify equipment cleanliness and status before use.
- Check area readiness and line clearance before batch processing.
- Ensure applicable equipment calibration and preventive maintenance status is valid.
- Monitor environmental and process conditions as applicable to the assigned area.
- Escalate any abnormality or quality risk to the QA supervisor.
F. Audit and Training Support
- Support internal audits, customer audits, and regulatory inspections.
- Assist in preparation and maintenance of GMP documentation.
- Participate in GMP, GDP, SOP, and data integrity training.
- Follow up on audit observations and corrective actions as assigned.
3. Required Skills
- Knowledge of pharmaceutical manufacturing and packaging operations.
- Understanding of cGMP, GDP, SOPs, BMRs, and BPRs.
- Basic understanding of deviations, CAPA, change control, and risk assessment.
- Good documentation and communication skills.
- Attention to detail and ability to identify quality-related discrepancies.
- Ability to work collaboratively with Production, QC, Warehouse, and other departments.
4. Experience Requirements
- 1–3 years of relevant experience in IPQA or pharmaceutical Quality Assurance.
- Practical exposure to shop-floor QA activities and line clearance is preferred.
- Experience in BMR/BPR review and in-process checks is desirable.
5. Key Performance Indicators (KPIs)
- Timely completion of in-process checks.
- Accuracy and completeness of batch documentation.
- Compliance with line clearance and GMP requirements.
- Timely reporting of deviations and non-conformities.
- Timely closure of assigned CAPA actions.
- Reduction in documentation errors and repeat GMP observations.
6. General Responsibilities
- Follow all company policies, safety requirements, and approved procedures.
- Maintain confidentiality of company and product-related information.
- Perform other QA/IPQA duties assigned by the reporting manager.
- Ensure that any product quality concern is promptly reported and appropriately documented.
Pay: ₹16,000.00 - ₹20,000.00 per month
Perks:
- Food provided
- Health insurance
- Leave encashment
- Provident Fund
Work Location: In person
📌 IPQA Officer (Baddi)
🏢 AZENTYX HEALTHCARE
📍 Baddi