🔹 Job Title: Senior Executive – IPQA
📍 Location: Dahej SIR, Gujarat, India
🕓 Job Schedule: Full-Time
🧾 Job Category: Quality Assurance
🎓 Qualification: M.Sc (Organic Chemistry) / B.Pharm (Preferred)
🧠 Experience: Minimum 8 years in IPQA activities within an API manufacturing unit
📅 Posting Date: 26/09/2025, 11:51 AM
📅 Apply Before: 15/10/2025, 02:21 AM
🆔 Job Identification: 6527
🏢 Workplace Address: Plot No. Z/111/A, Dahej SEZ Limited, Bharuch, Gujarat, IN
🔹 Key Responsibilities:
🏭 Shop-Floor & Process Compliance
Conduct regular plant rounds to monitor production activities and ensure adherence to SOPs and GMP standards.
Provide line clearance at product changeovers and critical process steps.
Escalate any deviations or discrepancies observed during rounds or documentation review.
📘 Documentation & Review
Review Batch Manufacturing Records (BMRs), Batch Cleaning Records (BCRs), and analytical records prior to API release.
Support documentation control activities, ensuring timely filing, retrieval, and record accuracy.
Maintain and monitor controlled and retained sample records for intermediates, finished APIs, and KSMs.
Ensure strict adherence to Good Documentation Practices (GDP) and data integrity principles.
🧪 Sampling & Quality Checks
Perform sampling of APIs, intermediates, and Key Starting Materials (KSMs).
Ensure proper cleaning and maintenance of sampling tools as per SOPs.
🔹 Additional Responsibilities:
Support internal and external audits by providing required documentation and compliance data.
Assist in preparation and review of SOPs related to IPQA activities.
Participate in training programs to stay updated with quality, compliance, and regulatory standards.
Coordinate effectively with QA, QC, and Production teams for timely resolution of quality issues.
🔹 Required Skills:
|
Skill Area |
Proficiency |
|---|---|
|
GMP / cGMP Compliance |
Intermediate |
|
In-Process Quality Assurance & Line Clearance |
Intermediate |
|
Documentation Control & Review |
Intermediate |
|
Data Integrity & GDP |
Intermediate |
|
Sampling Procedures & Sample Management |
Intermediate |
|
Record Management & Compliance |
Intermediate |
|
Team Coordination & Shop-Floor Presence |
Basic |
🔹 Qualifications:
🎓 Education:
M.Sc – Organic Chemistry (Preferred)
B.Pharm (Preferred)
🧠 Experience:
Minimum 8 years in IPQA within an API manufacturing environment
🗺️ Workplace Address:
Plot No. Z/111/A, Dahej SEZ Limited, Bharuch, Gujarat, India
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