Senior Manager

Job Description

Job Title: Senior Manager/ Manager Job Location: Bangalore Job Grade: 6About Syngene: Syngene (www.syngeneintl.com) 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 spiritMandatory expectation for all roles as per Syngene safety guidelinesOverall 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 timeCore Purpose of the Role:Overall lead for Analytical Development, Validations, Stability studiesRole Accountabilities:Overall responsible for the functioning of Analytical Laboratory. To ensure cGMP, GLP and GDP on regular work carried on and to follow regulatory compliance. Sound knowledge of Analytical method Development and trouble shooting. Should have acquainted with all regulatory guidelines. Experience on Analytical method validations and Transfer. Sound communication to interact with clients. Should be able to guide team for carrying out investigation and review reports in case of incidents, deviations, out of calibration and CAPA. Regular client interaction via telecom or e-mails (if required). Review of SOP s, IOP s and EOP s as per the quality requirements. Commitment to safetyLeadership CapabilitiesGood Interpersonal skills Team & Time management Relationship management - Internal & ExternalSyngene ValuesAll employees will consistently demonstrate alignment with our core valuesExcellence Integrity ProfessionalismAccountabilities as a Syngene Leader (only for Leadership Hires) Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.Specific requirements for this roleExperience15-20 yearsSkills and Capabilities:Sound knowledge on pharmaceutical analytical sciences. Sound understanding of GxP and regulatory requirements. Effective communication skills both written and verbal. Good Interpersonal skills Team & Time management Relationship management - Internal & ExternalEducation M.Pharma/ B.Pharma /Ph. D,

Keyskills :
method developmentoccupational healthsalesclient interactionanalytical development