Senior Executive-QA

. Assist in developing Technology Transfer, Validation strategies and plans for new
processes, systems, and products.
. Ensure alignment with regulatory requirements and industry standards.
- r Execution of Validation and Technology Transfer Activities: . Coordination with different departments for performing Technology Transfer, Validation
activities and for preparation of BMR/BPR and Execution of validation activities as per
VMP.
. Coordinate and perform Technology Transfer and Validation according to approved
protocols and schedules.
Documentation:
. Preparation of SOPs, Batch manufacturing records, Batch Packaging records and
supporting documents.
. Preparation of protocols and reports for Optimization, Submission and Validation,
cleaning validation and hold time.
. Maintain accurate and complete validation documentation, including protocols, reports,
and validation summaries.
. Preparation & review of risk assessment of process and product etc.
. Preparation and execution of temperature excursion and Transportation study of product.
. Review of BMR, BPR for their correctness & completeness.
: r Support for Technology Transfer and Validation: . Assisting Technology transfer and validation projects from initiation through completion.
. Coordinate with cross-functional teams (e.g., Manufacturing, QC, QA, warehouse &
Engineering) to ensure timely completion activities.
- Compliance and Quality Assurance:
. Ensure compliance with regulatory requirements and company quality standards.
. Participate in internal and external audits related to validation activities.
. Support to site DICO (Data lntegrity Compliance Officer) for monitoring and
implementation of actions related to Data lntegrity awareness at site.

Bachelor of PharmacyiMaster of Pharmacy or Master in Science,
Technical background is preferred.