Development Quality professional

JOB DESCRIPTION

Job Title: Specialist Development Quality Assurance

Department: Discovery and Development QA

Job Location: Bengaluru, India

About Syngene:  Syngene ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

 Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company's integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene' s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

 Profile Description:

This role will be responsible for crafting the allocation methodologies and process flows for Development services. This individual will collaborate actively with Operation units of development services to improve alignment and achievement of customer satisfaction and value realization

Core Purpose of the Role :

Responsible for Quality Systems of Development Services and relevant QA activities.

Role Accountabilities

1. 
   
2. Responsible to drive Phase gate for Product Development across Formulation Development functions.
3. Review and approval of Formulation development reports, QbD reports, risk assessment reports, Hold time study reports and other documents generated for formulation development projects.
4. Review and Assess risk associated with process and Mitigation Plan.
5. Review and provide inputs on analytical method to have robust methods.
6. Review and approval of Formulation Technology Transfer from Development services to Manufacturing.
7. Review and approval of Method transfer documents and Specifications for all early and late phase programs.
8. Review and approval of formulation development reports and QbD reports during development.
9. Review and approval of  transfer protocols & reports.
10. Coordination with cross-functional teams to complete the assigned work on time and data review.
11. Responsible for reviewing scientific experiments as per project requirements in a process development laboratory catering to formulation development.
12. Providing the exact root cause for the issues and performing why-why analysis to understand the challenges
13. Review of Quality Assurance procedures in EDMS.
14. Contributing to development procedures, practices, and systems that ensure safe operations and compliance with the company's integrity & quality standards.
15. Providing the exact root cause for the issues and performing why-why analysis to understand the challenges
16. Review and implementation of cross-deployment of CAPAs across Development OUs.
17. Support for facing Customer audits and their related compliance.
18. Support for handling customer queries related to quality & compliance with Development OUs.
19. Overall adherence to safe practices and procedures of oneself and the teams aligned
20. Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace.
21. Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace.
22. Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self
23. Compliance with Syngene quality standards and Data integrity policies always.
24. Hold self-accountable for the achievement of safety goals

The Successful Applicant 

1. 
   
2. Master's degree in Pharmacy, Master's in chemistry/ life sciences both preferable
3. Minimum years of experience in pharma industry in process development and chemical development, with at least 5- 10 years of process development environment/manufacturing.
4. Proven track record of successfully managing and leading respective time.
5. Sound knowledge of formulation development techniques .
6. Sound knowledge on Guidelines such as ICH, USP etc
7. Strong understanding of regulatory requirements
8. Excellent communication, Interpersonal and problem-solving skills
9. Ability to work effectively with cross functional teams and OU's.
10. Technology Transfer development to manufacturing.
11. Knowledge to set acceptance criteria for process validation and transfers, Handle technology transfer and data review as apert of transfer.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Experience

• 10+ years of relevant experience

Skills and Capabilities

• Exposure to Drug Development and Commercial
• Technology Knowhow
• Compliance management
• Process Excellence
• Execution focus'
• Accountability
• Collaboration .

Education

Master's degree in Pharmacy, master's in chemistry / life sciences or Ph.D in both preferable.