Baxter Hiring For Manager ADL
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Baxter Hiring For Manager ADL |
Position: Manager ADL
Location: Ahmedabad, Gujarat, India
What you'll bring !
14+ yrs of experience in Method development with prior exp in injectables is preferred
Experience handling investigation, Trouble shooting from plant investigation standpoint
Masters in Pharma or equivlent stream is mandatory
Experience handling and nurturing the Mid-Sized team
Person should have good communication and collaborator and required leadership skills.
Your Role at Baxter
This is where your work saves lives
The research we do and the products we develop improve outcomes for patients around the world. As a Manager - ADL at Baxter, your work contributes directly to making a significant impact on others. It's challenging work—and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Whether guiding a team through a project or managing direct reports, our research and development team is responsible for influencing others to achieve results.
Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.
What you'll be doing !
Planning and monitoring of Validation, Postproduction and Query related studies as per schedule and work allocation to analyst.
To provide the technical support/mentorship to the QC lab during OOS/OOT investigations
To ensure in depth understanding of the project and to provide all Regulatory submission documents as per committed timelines.
To guide the team in resolving the technical challenge (if any) observed during the execution of analytical activity and to keep the department head advised in case of any deviation from the committed timeline
To keep track of the activities assigned to the team and ensure timely completion as per stipulated timelines
Ensure availability of required resources well in advance for smooth functioning of analytical activities of the team.
To resolve any analytical issue observed during the study and to ensure proper investigation of non-conformance of results.
To Provide response to the queries received from various regulatory agencies in scientific/logical manner within the stipulated timeline.
Review and approval of Standard Operating Procedures.
To check the pre-requirement for Installation of Instruments and to ensure installation and qualification of Laboratory instruments in timely manner as per organization requirement.
Track regulatory commitments and take appropriate action from analytical GMP function
Collaborate with cross functional team members i.e., project management, Regulatory Affairs, Formulation development, manufacturing, and quality control for smooth execution of projects from analytical perspective
To review the status of daily work of the team and report to the Manager on daily basis.
To review and to implement safety requirements as per policy.
To ensure compliance/mitigation of HAZID, E&C, Data integrity, training & cGLP followed in the team
Responsible for timely closure of LIR, NCR, CCN, CAPA and to ensure the implementation of appropriate Corrective and Preventive action wherever required
Ensure compliance to Pharmacopoeia update for the assigned projects in timely.
Adherence to the Baxter’s Code of conduct principles, SOP compliance pertaining to Analytical, quality and R&D site
To understand and ensure cGLP within ADL GMP function
To provide support to the manufacturing plant during Quality inspections performed by the regulatory agencies
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