About the Role

Requirement for Winhycare Pharma Division.

WinHycare Pharma is looking for an experienced QA Executive – Aseptic Filling & Lyophilization to provide hands-on Quality Assurance oversight across sterile injectable and peptide lyophilization operations.

The role will be responsible for ensuring compliance with GMP requirements, approved procedures, batch records, data-integrity requirements and applicable sterile-manufacturing regulations.

Key Responsibilities

- Provide QA oversight for dispensing, compounding, sterile filtration, aseptic filling, stoppering, capping and visual inspection.
- Verify line clearance, equipment status, sterilization and depyrogenation activities.
- Monitor environmental and personnel-monitoring status and aseptic practices.
- Oversee lyophilization operations, including loading, cycle initiation, stoppering and unloading.
- Review critical lyophilization parameters including shelf/product temperature, chamber pressure, vacuum and condenser temperature.
- Review cycle trends, alarms, deviations, interventions and endpoint determination.
- Support cycle development, scale-up, qualification and process validation.
- Review batch records, electronic records, audit trails, sterilization records and filter-integrity results.
- Handle deviations, investigations, CAPA, change controls and risk assessments.
- Participate in IQ/OQ/PQ, media fills, cleaning validation,



process validation and lyophilization-cycle qualification.
- Support regulatory inspections, customer audits and internal quality-system activities.

What We're Looking For

Required:

- 4–6 years of pharmaceutical QA experience.
- Hands-on experience in sterile injectables and/or lyophilized products.
- Solid knowledge of GMP, GDP and data integrity.
- Good understanding of aseptic processing and cleanroom practices.
- Ability to independently identify, escalate and challenge quality risks.
- Strong batch-documentation, investigation and communication skills.

Preferred:

- Experience with peptides, proteins, biologics or high-value products.
- Exposure to small-batch aseptic manufacturing.
- Experience with lyophilized formulations and 2–8°C cold-chain products.

Technical Expertise

Candidates should have practical knowledge of:

Lyophilization | Aseptic Filling | Sterile Filtration | Media Fills | Environmental Monitoring | GMP | ALCOA+ | Data Integrity | CAPA | Deviation Management | Validation | Risk Assessment | Container-Closure Integrity

Why Join WinHyCare Pharma?

Be part of a team working on sterile injectable and peptide manufacturing operations, where quality, compliance and patient safety are central to every stage of production.

? Location: Hyderabad

? Apply: [email protected]

? Website: winhycare.com

? Contact Number: +91 (phone hidden)

📌 QA Executive - Aseptic Filling & Lyophilization (Hyderabad)
🏢 WinHycare
📍 Hyderabad