We are Galentic Pharma (I) Pvt Ltd,. Our current open job opening in Quality Assurance - Validation Officer department.
Galentic Pharma (I) Pvt Ltd is a USFDA approved manufacturing unit in semisolid dosage. Plant located at Gandhidham -Kutch (Gujarat). We required talented, hardworking and work dedicated candidate for our Gandhidham unit.
Share cv : What App no. 63579 38032 / 99134 68943
Core Responsibilities :
- Protocol Development: Draft, review, and execute validation protocols for equipment, utilities, cleaning processes, and manufacturing methods.
- Qualification Lifecycle Management: Manage Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Regulatory Compliance: Ensure all procedures and equipment comply with cGMP, FDA, and EMA regulatory guidelines.
- Risk Assessment & CAPA: Assist with identifying quality risks and help formulate Corrective and Preventive Actions (CAPA) and deviations.
- Data Review: Review executed documents, master batch records, and calibration certificates across cross-functional teams.
Key Qualifications
- Education: A Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, or Master of Science (M.Sc).
- Experience: Typically 2 to 8+ years of validation experience in highly regulated pharmaceutical or biotech environments.
- Skills: Strong understanding of cGMP, proficiency with validation instruments (e.g., data loggers), excellent report writing abilities, and attention to detail.
Pay: ₹20,000.00 - ₹30,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
Work Location: In person
