Analytical Development

Designation: Analytical Development - HPLC

Job Location: Bangalore

The Company

Syngene International Ltd. (BSE: 539268 NSE: SYNGENE ISIN: INE398R01022) is an integrated research development and manufacturing solutions company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors. Syngenes 4500 scientists offer both the skills and capacity to deliver great science robust data management and IP security and quality manufacturing at speed to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery development and manufacturing facilities as well as dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Result Areas

Role-specific:

Functional Responsibilities:

• Responsible & accountable towards safety & compliance in all the work activities in the own responsibility area(s).
• Monitor & confirm that the established Environment Occupational Health Safety and Sustainability (EHSS) practices for safe work environment are followed.
• Adhere to the highest standards of quality integrity & compliance for every work activity.
• Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar.
• Attend all assigned mandatory trainings related to data integrity health and safety measures.
• Participate in & support the trainings on procedures protocols and On-the-Job activities.
• Compliance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s).
• Participate in & support for on-time initiation & closure of deviations investigations CAPA and change controls.

Primary Responsibilities:

• Sample analysis for in-process finished product stability and miscellaneous samples.

• Responsible to troubleshoot problems provide technical guidance train lab personnel in fundamental lab techniques and procedures as a mentor and coach.
• Responsible for supporting the routine testing operations ensuring compliance with regard to observation data sheet along with the analytical data analysis report and handing over the same on time to QA or the Client.
• Preparation and review of batch release documents like STPs with observation data sheet Method transfer and validation protocols etc.
• Responsible to review of Analytical data QMS documents related to batch release and stability study activity related documents.

• Responsible to review the Method transfer Method validation& Verification protocols. Coordinating and supporting for the review and release of Method transfer Method validation & Verification activity and its records/reports and results.

• Responsible to manage a team supporting for routine testing operations Ensuring Compliance with regard to observation data sheet along with the analytical data analysis report on time to QA and Customers.

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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