Quality Management System - Jr Executive

1-2 years

Not Disclosed

Hyderabad

10 Feb. 10, 2025

Job Description

Job Type: Full Time 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

Job Title: Quality Management System - Jr Executive
Experience: 1-2 years
Location: Hyderabad
Employment Type: Full-Time

Job Summary:

As a Junior Executive in the Quality Management System (QMS) department, you will be responsible for implementing and maintaining quality systems that comply with cGMP standards. You will assist in the preparation, review, and control of quality documentation, ensure adherence to regulatory guidelines, and contribute to maintaining the quality standards of the plant.

Key Responsibilities:

Implementation of cGMP System:
- Assist in the implementation and maintenance of current Good Manufacturing Practices (cGMP) within the plant to ensure compliance with regulatory standards.
SOP Preparation & Review:
- Prepare and review Standard Operating Procedures (SOPs) to ensure they are up-to-date and align with quality guidelines and operational needs.
Formats & Logbooks Management:
- Issue and retrieve formats, logbooks, and registers as per respective procedures to maintain accurate records and ensure proper documentation practices.
Quality Documents Management:
- Prepare, review, and control quality documents such as SMF (Standard Manufacturing Form), Quality Policy, and other relevant documentation.
Deviation & Incident Management:
- Issue, review, and compile deviations, incidents, and change control reports, and assist with the root cause analysis to ensure compliance and prevent recurrence.
CAPA Implementation:
- Initiate, review, and ensure the proper implementation of Corrective and Preventive Actions (CAPA) to address non-conformities and improve processes.
Self-Inspection Handling:
- Assist in the handling and coordination of self-inspections, ensuring that the plant maintains high-quality standards and adheres to regulatory requirements.
Training Coordination:
- Coordinate training programs for staff members to ensure that they are well-versed in quality standards, procedures, and regulatory requirements.
Market Complaints & Product Recall Management:
- Handle market complaints and product recalls, ensuring that necessary actions are taken to resolve issues and maintain customer satisfaction.
Document Storage & Retention:
- Manage document storage and retention processes, ensuring that quality-related documents are stored appropriately and in compliance with regulatory requirements.
R&D Activities Support:
- Provide support for Development Quality Assurance (DQA) in handling R&D activities to ensure that new products and processes meet quality standards.

Qualifications and Skills:

Educational Background:
- Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related field.
Experience:
- 1-2 years of experience in a quality management role within the pharmaceutical or medical device industry, with exposure to cGMP systems and quality documentation.
Knowledge & Skills:
- Strong understanding of cGMP and regulatory requirements.
- Experience with quality documentation, including SOPs, deviations, change controls, CAPAs, and self-inspections.
- Ability to handle market complaints and product recalls effectively.
- Exposure to R&D activities and Development Quality Assurance (DQA) would be an advantage.
Communication & Coordination:
- Strong communication skills to effectively coordinate training programs and manage documentation processes.
- Attention to detail and strong organizational skills to handle quality-related documentation and records.
Problem-Solving:
- Ability to identify issues, conduct root cause analysis, and implement corrective actions.

Why Join Us?

Promea Therapeutics offers an excellent opportunity for a motivated professional to develop their career in quality management systems. This role is ideal for someone eager to contribute to the healthcare and pharmaceutical industry by ensuring the implementation of high-quality standards in a dynamic environment.

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Quality Management System - Jr Executive

Job Description

Job Summary:

Key Responsibilities:

Qualifications and Skills:

Why Join Us?

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