Job Description Summary
As a Director R&D Compliance, will be a key player in shaping and driving our R&D functions overall quality strategy. While each sites have its own QA resources, your role spans across all of R&Ds and all product development groups, making it more strategic in nature. Your role will involve setting high standards, defining best practices, and establishing robust quality assurance processes across all teams in R&D- Product Development and Analytical Research Development.
Job Description
JD: -
Strategic Development Quality Assurance
- Responsible for developing and implementing a quality strategy aligned with R&D objectives.
- Responsible for setting high standards, defining best practices, and establishing robust quality assurance processes across all teams in R&D- Product - - - Development and Analytical Research Development.
I- identifies compliance risk areas and assists with developing strategies to address risk areas.
- Foster a company culture that focuses on compliance and ensures on-going commitment to the Endo Values and Behaviors
Matrix and Reporting: -
- will be responsible defining and monitoring key quality metrics, providing regular reports to senior management to ensure transparency and accountability in our quality assurance efforts. You will also help secure the necessary data sources for accurate analysis.
Training and Development: -
- Provide guidance and support to compliance leaders and team members, and other product team members in R&D to enhance their quality skills and knowledge.
Quality System :-
- Investigation on existing cause of nonconformity/problem pertaining to product/process.
- Responsible for quality surveillance & monitoring of compliance with Requirements of cGMP.
- Responsible for SOP, Guideline or policy preparation and implementation.
- Responsible for Monitoring of Quality System and Internal Auditing.
- To ensure compliance with approved procedure, SOP's, data integrity, current Good Laboratory Practices (cGLP), and regulatory agency for all data generated.
- To maintain quality and compliance in ARD Lab by identifying quality requirements, disseminating standards, policies and procedures.
- To ensure compliance of standard operating procedure (SOP) laid down by other PAR formulation sites (Labs, production facilities etc.), including laboratory safety, as applicable.
- Interact with Quality Assurance department during inspections or any internal audit conducted by QA.
- To prepare and review audit compliance for Audit findings/observations. To submit and review Audit findings/audit compliance report as per timelines for the observations and recommendations and ensure proper CAPA provided for audit observations.
- To lead any regulatory audit conducted by regulatory agencies.
- To participate in continuous improvement initiatives relates to quality activities.
Documents Review: -
- To ensure timely quality review of R&D development data.
- To ensure quality review of R&D equipments qualification records, periodic calibration documents, audit trial of computerized systems, preventive maintenance records, master calibration schedules etc.
- To ensure timely review and ensure adequacy of analytical method validation and transfer documents incase required.
Research and Innovation:-
- Stay up to date of industry trends and emerging technologies in quality assurance, especially in the area of AI.
- Drive innovation in QA practices to continuously enhance product quality and maintain our competitive edge.
Collaboration & Leadership :-
- Collaborates with business and Compliance / quality colleagues and may serve as the lead for key Compliance initiatives in support of the R&D.
- To co-ordinate with cross functional teams for the timely completion of assigned group activities.
- To collaborate with other groups/CFTs within the organizations to support execution of Audits and deploy compliance initiatives.
Education & Experience:-
- Postgraduate in Chemistry / Pharmaceutical Quality Assurance.
- 15+ Yrs of working experience in R&D QA in a reputed pharmaceutical organization
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each persons unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
