Instagram
youtube
Facebook

Senior Executive, Ipqa

8 years
Not Disclosed
10 Oct. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🔹 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