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Certified Qualification Specialist

1 month ago


Vizag, Andhra Pradesh, India Dr Reddy's Laboratories Limited Full time

At Dr. Reddy's Laboratories Limited, we are seeking a highly skilled Certified Qualification Specialist to join our team. This is an exciting opportunity for a dedicated professional to contribute to the success of our organisation.

About Us

We are a global pharmaceutical company with a legacy of excellence and a commitment to delivering quality medicines to patients worldwide. Our state-of-the-art manufacturing facilities operate across various locations, including Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, covering 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.

Job Summary

We are looking for an experienced Certified Qualification Specialist to oversee the documentation and execution of qualification activities, including preparation, review, and execution of various qualification documents. The ideal candidate will have expertise in working with sterile product facility-related validations, such as equipment validation, media fill, cleaning validation, process validation, area qualification, and other miscellaneous qualifications.

Responsibilities
  1. Documentation and Execution: Prepare, review, and execute URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ, and miscellaneous qualification documents.
  2. Risk Assessment and Preparation: Review and prepare risk assessments for equipment and systems.
  3. Factory Acceptance Test and Site Acceptance Test: Oversee new project-related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test).
  4. Data Compilation and Reporting: Review and compile raw data, relevant certificates, analysis test reports, and preparation and review of final summary reports.
  5. Media Fill Validation and Cleaning Validation: Prepare and review protocols and reports for media fill validation and cleaning validation.
  6. Change Request and Action Plan Management: Initiate relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval.
  7. CAPA Implementation and Incident Investigations: Implement corrective and preventive actions and handle incident investigations and CAPA related to qualification.
  8. Training and Development: Conduct training for employees and external vendors as a qualified trainer.
  9. Qualification SOPs and Investigations: Prepare and review qualification SOPs (Standard Operating Procedure), conduct investigations as a site investigation team member, and update Qualification status label.
Requirements
  • Education: An M.Pharm, B Pharm, B Tech, or BSC degree.
  • Experience: Minimum 5+ years of experience in sterile product facility-related validations.
  • Skills and Attributes: Technical skills: experience in working with sterile product facility-related validations; behavioural skills: effective communication, attention to detail, problem-solving, and time management.
Benefits

We offer a competitive salary ranging from $80,000 to $120,000 per annum, depending on experience and location. Additional benefits include joining and relocation support, family support (maternity and paternity benefits), learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself.