India's DMPLOI - Jobs & Networking AppCLAPS Industries Pvt. Ltd., a growing pharmaceutical organization, has announced an exciting opportunity for experienced professionals in the Quality Assurance domain. The company is currently hiring a QA Documentation Executive with an interest in transitioning into or building a career in Regulatory Affairs. This position offers exposure to international regulatory requirements, documentation management, and pharmaceutical compliance systems.
The role is ideal for candidates who possess strong knowledge of GMP documentation practices and are looking to expand their expertise in regulatory submissions and global market registrations.
Position Overview
Job Title: QA Documentation Executive
Department: Quality Assurance / Regulatory Affairs
Location: Ahmedabad, Gujarat, India
Experience Required: Minimum 2 Years
Qualification: B.Pharm, M.Pharm, or relevant pharmaceutical qualification
Key Responsibilities
The selected candidate will be responsible for managing and controlling critical pharmaceutical documentation while ensuring compliance with regulatory standards.
Major responsibilities include:
Preparation and control of SOPs, STPs, specifications, formats, and master documents.
Review of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), deviations, CAPA records, and change controls.
Maintenance of document management systems and archival records.
Compilation and preparation of CTD/ACTD dossiers.
Handling product registrations, renewals, and variations for ROW (Rest of World) markets.
Coordination with QA, QC, Production, Purchase, and Regulatory Affairs teams.
Ensuring compliance with GMP, GDP, and ICH guidelines.
Responding to regulatory queries and maintaining submission trackers.
Required Skills and Knowledge
Candidates applying for this position should possess:
Strong understanding of GMP and GDP documentation requirements.
Knowledge of document control systems and quality management practices.
Familiarity with deviations, CAPA, and change control procedures.
Good communication and technical writing skills.
Proficiency in Microsoft Office applications.
Interest in developing a career in Regulatory Affairs.
Preferred Qualifications
Additional advantages include:
Basic knowledge of CTD/ACTD dossier preparation.
Understanding of ICH guidelines and international registration processes.
Attention to detail and a compliance-focused approach.
Ability to work collaboratively across multiple departments.
Career Growth Opportunities
This position offers excellent career progression for professionals interested in pharmaceutical regulatory affairs. Employees will gain valuable exposure to:
Global pharmaceutical regulations.
International dossier preparation.
Product registration processes.
Regulatory compliance management.
Cross-functional pharmaceutical operations.
The role serves as a strong foundation for advancing into Regulatory Affairs Specialist, Regulatory Executive, or Compliance Management positions.
How to Apply
Interested candidates can submit their updated CV to:
Email: hr@clapspharma.com
Contact: +91 7802814488
Company: CLAPS Industries Pvt. Ltd.
Website: www.clapspharma.com
Technical FAQs
1. What is the role of GMP documentation in pharmaceutical quality systems?
GMP documentation provides documented evidence that manufacturing, testing, and quality processes are performed consistently and according to approved procedures. It ensures traceability, compliance, and product quality throughout the product lifecycle.
2. What are CTD and ACTD dossiers?
CTD (Common Technical Document) and ACTD (ASEAN Common Technical Dossier) are standardized formats used for pharmaceutical product registrations. They contain quality, safety, efficacy, and regulatory information required by health authorities.
3. What is the significance of CAPA in pharmaceutical manufacturing?
CAPA (Corrective and Preventive Action) is a systematic process used to investigate deviations, identify root causes, implement corrective measures, and prevent recurrence, thereby improving overall quality compliance.
4. How does Change Control support regulatory compliance?
Change Control ensures that any modification to processes, equipment, materials, or documents is evaluated, approved, documented, and implemented without negatively affecting product quality or regulatory compliance.
5. Why are ICH guidelines important in Regulatory Affairs?
ICH (International Council for Harmonisation) guidelines provide globally accepted standards for pharmaceutical development, manufacturing, quality, safety, and efficacy, helping companies achieve regulatory approval across multiple international markets.
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