Senior Executive

4-6 years

Not Disclosed

Remote

10 Feb. 11, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Position: Senior Executive - Quality Assurance
Department: Quality Assurance
Location: Unit 2
Experience Required: 4-6 years
Educational Qualification: M.Pharm, M.Sc
Date Posted: 30-11-2023

Job Summary:

The Senior Executive in the Quality Assurance (QA) department plays a pivotal role in ensuring the continuous improvement and compliance of Quality Management System (QMS) practices. This includes performing GAP assessments, managing key QMS documents, and assisting in validation and qualification activities. The Senior Executive is also responsible for in-process quality checks and ensuring shop floor compliance.

Key Responsibilities:

GAP Assessment & QMS System Improvement:
- Perform GAP assessments for SOP versus current practices, identifying discrepancies.
- Identify gaps in the QMS system and ensure they are rectified as per the expectations outlined in EU annexures.
QMS Documentation Management:
- Oversee key QMS documents such as Change Control, Deviation, OOS (Out of Specification), CAPA (Corrective and Preventive Actions), incidents, APQR (Annual Product Quality Review), and investigations.
- Ensure timely closure and follow-up on these documents.
- Trend and track QMS documents for continuous improvement.
Online Document Review & Monitoring:
- Responsible for the review of online documents and ensuring compliance with relevant standards.
- Monitor dispensing of RM/PM, line clearance, IPQA (In-Process Quality Assurance) activity, and verification of status labels.
In-process Quality Assurance:
- Conduct In-process Quality Assurance checks for Quality Control (QC) and production teams.
- Follow up on corrective actions resulting from QA checks and audits.
Review of Product Documentation:
- Review in-process and finished product documentation, including Technical Data Sheets (TDS) and Certificates of Analysis (COA), ensuring accuracy and compliance.
Shop Floor Compliance:
- Ensure that the shop floor activities comply with the required quality standards and guidelines.
Qualification Activities:
- Handle qualification activities such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) in coordination with user departments and engineering teams.
Validation Assistance:
- Assist in validation activities at the manufacturing site, ensuring alignment with compliance requirements and industry best practices.
APQR Preparation & Review:
- Participate in the preparation and review of the Annual Product Quality Review (APQR), ensuring all required data is included and compliant.

Skills & Qualifications:

Educational Qualification:
- M.Pharm, M.Sc or a relevant field.
Experience:
- 4-6 years of experience in Quality Assurance, preferably in pharmaceutical or related industries.
Core Skills:
- GAP assessment for SOP vs. current practices.
- Strong knowledge of QMS systems and EU annexure expectations.
- Experience with key QMS documents (Change Control, Deviation, OOS, CAPA, APQR).
- Ability to trend and track QMS documents for process improvement.
- Familiarity with in-process checks, dispensing, line clearance, and verification of labels.
Additional Skills:
- Excellent attention to detail and problem-solving skills.
- Strong communication and interpersonal skills for collaborating across departments.
- Experience in qualification and validation activities (IQ, OQ, PQ).
- Familiarity with compliance and shop floor audits.

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Senior Executive

Job Description

Job Summary:

Key Responsibilities:

Skills & Qualifications:

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