Senior Executive – Technical Writing (Pharmaceutical Manufacturing & Regulatory Documentation)
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Experience Required: 3–6 years in pharmaceutical technical writing, validation, or regulatory documentation
Job Overview
We are seeking a highly skilled Senior Executive – Technical Writing to support pharmaceutical documentation, validation, and regulatory compliance activities. This role involves close collaboration with global teams, particularly US stakeholders, to ensure the preparation and delivery of high-quality, compliant technical documents within defined timelines.
The ideal candidate will have strong experience in manufacturing documentation, validation protocols, and regulatory submissions, with a keen eye for detail and compliance standards.
Key Responsibilities
Collaborate with global teams to prepare, review, and deliver high-quality technical documents within project timelines
Develop and review process validation and product quality documents including PPQP, PPQR, PSP, PSR, CPVP, BBHS, and regulatory modules for submission and validation batches
Prepare and review cleaning validation documentation including CVP, CVSR, CVR, and matrix documents, along with monitoring Annual Cleaning Verification Programs, DEHT, and CEHT
Handle quality events such as Change Controls (CC), Unplanned Deviations (UD), Planned Deviations (PD), incidents, and customer complaints as required
Create and review manufacturing and packaging documents including Master Production Records (MPR), Batch Production Records (PBR), Master Packaging Specifications (MPS), and Standard Operating Procedures (SOPs)
Conduct technical assessments, deviation investigations, and root cause analysis reports
Ensure compliance with regulatory requirements, internal SOPs, and global quality standards
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
Strong understanding of pharmaceutical manufacturing processes and documentation practices
Proficiency in technical writing and document management systems
Excellent written and verbal communication skills
Preferred Skills and Experience
3–6 years of experience in pharmaceutical technical writing, validation, or quality documentation
Hands-on experience with regulatory submissions and validation documentation
Strong knowledge of GMP, regulatory guidelines, and quality systems
Ability to manage multiple projects and meet strict deadlines
Experience working with global or cross-functional teams
Work Environment and Growth Opportunities
Exposure to global regulatory and pharmaceutical manufacturing standards
Opportunity to work closely with international teams and stakeholders
Structured career growth in regulatory writing, validation, and quality assurance
Collaborative and compliance-driven work environment
About the Organization
The organization is a leading pharmaceutical company committed to delivering high-quality, affordable medicines globally. It fosters a culture of innovation, compliance, and continuous improvement, with a strong emphasis on diversity and inclusion.
Why Apply
This role offers an excellent opportunity to build expertise in pharmaceutical technical writing, validation, and regulatory documentation while working in a globally integrated environment focused on quality and compliance.
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