TM-Quality and Lab Compliance-Research Associate

Job Description

Designation: Executive/ Senior Executive (Level: 9-I/9-II) Department: BBRC-Translational Medicine (TM)-Quality and Lab Compliance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders, such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240-strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time-to-market and lower the cost of innovation. Job Purpose (1-2 Lines): At Syngene, the Translational Medicine organization (TM) at the Biocon Bristol-Myer Squibb R&D center (BBRC) integrates scientific and business insights of multiple functions, thereby providing innovative solutions that will make precision medicine a reality for the patients and health care providers we serve. The candidate will support the development, implementation and ensure TM organizational compliance to GLP, GCP, ISO 13485, CLIA and CAP requirements. Key Responsibilities: Roles and responsibilities include, but are not limited to the following:
• Develop, implement, and manage SOPs, work instructions, and compliance policies in support of GLP, GCP, ISO 13485 and CLIA/CAP lab operations.
• Ensure that record keeping is complete, and records are maintained appropriately by Translational Medicine lab staff. This includes ensuring the requisite standards are applied based on the intended use of the lab.
• Conduct regular internal diligence reviews and support internal audits to promote compliance in the labs.
• Assists with preparation for external audits and any required follow-up.
• Responsible for documenting corrective actions and developing plans to prevent future errors and improve processes.
• Prepares reports for periodic reviews of key quality and performance indicators across the labs.
• Ensures that correct training is assigned to the proper / relevant individuals
• Collate metrics on compliance and identifies ways to improve adherence to training plans.
• Assists in ensuring that employee qualifications and job descriptions (Employee Job Profiles) are maintained and updated on the required basis.
• Strive to continuously improve lab quality and productivity simultaneously.
Educational Qualification and experience:
• Bachelor s degree in a relevant scientific/healthcare discipline with 4-6 years of experience in compliance/QA OR
• Master s degree in Biology/Biochemistry/ Biotechnology or a relevant scientific/healthcare discipline with a minimum 2 years of QA/ Regulatory compliance or related experience.
Technical/functional Skills: (Maximum 4-6 Points)
• Knowledge of diagnostic/biomarker lab operations as well as GLP, GCP, and ISO 13485 requirements.
• Compliance focused and results driven.
• Demonstrated ability in writing documents supporting laboratory processes and workflows with a focus on regulatory oversight in a clear and concise manner.
• Has prior experience facing audits and closure of audit findings.
• Basic proficiency with tools and information technology systems, such as Microsoft Office, Project, Excel, Teams, Visio, etc.
• Experience working with diagnostics and biomarkers utilized over the various stages of drug discovery and development.
Behavioral Skills:
• Demonstrates effective communication skills (both oral and written), cross-functional collaboration skills, and a cross-cultural awareness.
• Proactive, works with a high level of independence with minimal supervision
• Good organizational, analytical, and planning skills.
• Attention to detail in documenting processes.
Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. ,

Keyskills :
documentationcalibrationeffective communication skillsvalidationresearchequal employment opportunitycontinuous improvement facilitation