Assistant Manager

Syngene International

Bangalore, Karnataka
Permanent
Full-time

1 day ago

JOB DESCRIPTIONDesignation: Method validation ExpertJob Location: BangaloreDepartment: Analytical Method Validation and Special InstrumentationAbout SyngeneAbout SyngeneAt 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 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 always 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 always
Hold self and their teams accountable for the achievement of safety goals
Govern and Review safety metrics from time to time

Job Description: Planning and allocation of Routine and non-routine activities for the entire team member. Investigation of QMS Elements and Report Generation, Approval and co-ordination with QA and Maintaining a QMS/TAT/TPA matrix.Key Responsibilities: * Planning and allocation of Routine and non-routine activities for the entire team member.

Interaction with production, ADL, R&D, QA and other department for QC related functions.
Interaction with client and Project team for the smooth functioning of project related activities.
To review the In-process, cleaning, intermediate and finished product specification.
Initiate the change control and taking approval from analytical QA.
Planning and allocation of Documentation preparation.
Review of routine/non-routine validation reports.
Review of method verification and method validation protocol.
Review of standard qualification protocol forced degradation protocol and method transfer protocol.
Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.
To maintain the sampling packing area
Investigate and close for planned and unplanned deviations.
Review of Certificate of analysis.
Approval of specification of Non-technical batches.
Responsible for Ensuring that the Good Laboratories Practices are followed while working in QC Laboratory.
Responsible for Ensuring the Use of required safety apparels while sampling, analysis and working in Laboratory.
Responsible for taking any other job allocated by Head of the Department.

To ensure safety compliance as per Syngene policy and EHSS requirements.Educational Qualification: M Sc / M Pharma (Analytical/General chemistry)Technical/Functional Skills: * Should be well versed with the latest analytical techniques like HPLC/GC, KF/KFC, IR/UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, etc...

Being well-versed in the Chromeleon data management application and LIMS will be advantageous.

Experience: 9 - 12 yearsBehavioural Skills:

Should be an adaptive learner.
Should demonstrate effective Communication skills.
Organization and ability to balance work and Life.
Should possess good Time Management abilities.

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 about public assistance, veteran status, or any other characteristic protected by applicable legislation or local law.

Syngene International

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