The Role
Leads quality assurance and quality control for pharmaceutical and specialty chemical products. Oversees GMP and QMS compliance, SOPs, deviations, OOS/OOT investigations, CAPA, change controls, analytical testing, method validation, supplier and CMO audits, customer complaints, regulatory audits, risk management, data integrity, and continuous improvement. Manages QA/QC teams, budgets, KPIs, laboratory capabilities, product qualification, and quality support for new product development and business expansion.
Summary Generated by Built In
About Scimplify
Scimplify is a specialty chemicals manufacturing company offering a full-stack solution—from R&D and custom synthesis to large-scale manufacturing and doorstep delivery. Headquartered in Bengaluru, India, we serve multiple industries ranging from pharmaceuticals to agrochemicals and industrial chemicals to personal care and fragrances.
We enable 1000+ business across 30+ countries to develop and scale innovative chemicals from lab to commercial production.We have raised $40 million in Series B funding, taking its total funding to $54 million. The round was co-led by Accel and Bertelsmann India Investments.We are a team of 450+ professionals with entities in India, Japan, USA, UAE, and Indonesia.
Job Summary:
Lead the overall QA & QC function for pharmaceutical and specialty chemical products, ensuring compliance with GMP, QMS, regulatory requirements and customer specifications.
Key Responsibilities:
- Lead QA & QC operations, QMS, SOPs, deviations, OOS/OOT, CAPA and change controls.
- Manage QC laboratory activities, analytical testing, method development, validation and transfer.
- Ensure quality compliance for raw materials, intermediates and finished products.
- Lead vendor/CMO qualification, audits and supplier quality management.
- Handle customer complaints, quality queries, specifications and customer audits.
- Coordinate regulatory, internal and external audits and ensure timely CAPA closure.
- Drive quality risk management, data integrity and continuous improvement.
- Develop and manage QA/QC team, KPIs, budgets and laboratory capabilities.
- Support new product development, product qualification and business expansion.
Qualification:
M.Sc. / M.Pharm / B.Pharm / relevant technical qualification.
Experience:
10–15 years for Senior Manager / 15–20+ years for DGM in Pharma, API, Specialty Chemicals or related industries.
Preferred:
Strong experience in GMP/QMS, analytical QC, method validation, vendor/CMO audits, customer audits, investigations and team leadership.
Skills Required
- M.Sc., M.Pharm, B.Pharm, or relevant technical qualification
- 10–15 years of experience for Senior Manager level in pharma, API, specialty chemicals, or related industries
- 15–20+ years of experience for DGM level in pharma, API, specialty chemicals, or related industries
- Strong experience in GMP and QMS
- Experience in analytical QC and method validation
- Experience conducting vendor/CMO audits and customer audits
- Experience with investigations and team leadership
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The Company
What We Do
Scimplify is a science-first company specializing in the end-to-end development and manufacturing of specialty chemicals, serving industries such as pharmaceuticals, agrochemicals, and industrial chemicals.
