Executive/Senior Executive ? Project Management
Hetero · Not specified · onsite · Posted 72d ago
Undisclosed3–6 yrsfulltimeSourced from
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About this role
Job Summary
Key Responsibilities
Required Skills
Qualification
Experience
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
We are seeking a highly motivated Project Management Professional with 36 years of experience in the API/CDMO pharmaceutical industry. The ideal candidate should have exposure to Technology Transfer (TSD), Production, Quality Assurance (QA), or Quality Control (QC) and be capable of managing projects from development through commercial manufacturing while coordinating with cross-functional teams and customers.
Key Responsibilities
- Manage end-to-end project activities from technology transfer to commercial manufacturing.
- Coordinate technology transfer, process scale-up, engineering batches, validation batches, and commercial production.
- Collaborate with R&D, Production, QA, QC, Engineering, Supply Chain, Regulatory Affairs, and customers to ensure timely project execution.
- Prepare and monitor project timelines, milestones, deliverables, and risk mitigation plans.
- Support process validation, cleaning validation, equipment qualification, and technology transfer documentation.
- Coordinate customer technical discussions, project review meetings, and manufacturing readiness activities.
- Track project progress and provide regular status updates to customers and management.
- Ensure compliance with cGMP, ICH guidelines, Data Integrity, EHS, and global regulatory requirements.
- Review project-related documentation, deviations, CAPA, change controls, and validation reports.
- Support customer audits, regulatory inspections, and internal quality audits.
- Drive continuous improvement initiatives for project execution, process optimization, and operational excellence.
Required Skills
- Experience in Project Management , Technology Transfer (TSD) , API Production , Quality Assurance , or Quality Control .
- Strong understanding of API manufacturing processes and commercial operations.
- Knowledge of cGMP, ICH, Data Integrity, WHO-GMP, USFDA, EU GMP, MHRA, PMDA, and other regulatory requirements.
- Experience in process validation, analytical method transfer, equipment qualification, and project documentation.
- Knowledge of deviations, CAPA, change control, risk assessment, and quality systems.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication, stakeholder management, and cross-functional coordination abilities.
- Ability to manage multiple projects and deliver within defined timelines.
Qualification
- B.E./B.Tech Chemical Engineering or
- M.Sc. Chemistry / Organic Chemistry / Analytical Chemistry
Experience
- 36 years of experience in the API/CDMO pharmaceutical industry .
- Candidates with experience in Project Management, Technology Transfer (TSD), Production, QA, or QC are encouraged to apply.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
cleaning validationAPI ManufacturingCGMPMethod TransferauditsChemistrychemical engineeringCAPAChange ControlOrganic ChemistryehsEquipment QualificationApi ProductionCustomer AuditsManufacturingoperationscompliance
About Hetero
Hetero
Pharma
3.2k+
employees
1993
33 years old
Hyderabad/Secunderabad, Telangana
India
About
One of the world’s leading producers of key Active Pharmaceutical Ingredients and generic formulations with a presence in 140+ countries and backed by 30 years of experience in the pharma sectors.
Industries
PharmaHealthcare / PharmaClinical ResearchHealthcare
Employee ratings
4,524 reviews
3.9/ 5
Culture
3.6
Career growth
3.3
Work-life
3.8
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