Senior Executive – Quality Assurance (Capsule Division) - JG

Experience Required: 8+ yearsQualification: B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology)Work schedule: All Fridays off, alternate Saturdays off, and all Sundays workingAbout The OrganizationJoin a global manufacturing site that serves as the head office for a U.S.-based leader in Empty Hard Gelatin Capsules. The company specializes in capsule solutions for large animal health, pre-clinical studies, and medical device applications. With over 95% of sales directed to North America, the EU, and Japan, the organization also manufactures laboratory-scale pharma machines and maintains its own sales and distribution centers in the USA and Europe. It offers the intimacy of a small unit with the professionalism of an international enterprise.Key ResponsibilitiesEnsure manufacturing practices align with cGMP and GLP standards Manage QMS activities: change control, validations, stability, qualifications, APQR, risk assessments Coordinate applications for regulatory and statutory approvals (such as environmental clearances and export-related documentation) Organize and document internal/external audits (ISO, GMP+, FDA, and other relevant regulatory bodies) Evaluate and approve suppliers for RM, PM, testing labs, and service providers Assist in customer complaint analysis and reporting Investigate incidents, deviations, OOS; implement corrective actions Review operator availability and allocate tasks Maintain and review BMR documents; guide relevant updates Review and manage label artwork Required CompetenciesTechnicalAnalytical thinking and trend spotting Strong report writing and problem-solving skills Sound knowledge of GMP and GDP Proficient English communication (verbal & written) BehavioralQuality and service orientation Consistent delivery and time management Customer-centric mindset Cross-functional collaboration Reporting StructureReports to: Plant Head Manages: 2 Assistant Officers – QA Location & BenefitsTarapur MIDC, Boisar (1.5 hrs from Borivali by train or road) Direct suburban trains from Churchgate to Boisar Subsidized housing for bachelors and families Relocation allowance available What You’ll GainBe part of a niche, globally connected organization Work at the head office with international exposure Enjoy a small-company culture with MNC-level professionalism Participate in employee engagement programs and celebrations Medical insurance for immediate family Housing support for outstation candidates Skills: apqr,glp standards,quality control,quality assurance,ahc,iso,risk assessments,external audit liaison,testing labs,quality assurance processes,bmr documents,fda,aqcs,eia,qms activities,gmp+,cosmetics,animal health,qa process,pharmaceutical,cgmp,capexil,manufacturing