Job Information
Sun Pharmaceuticals, Inc Manager - 2 in India
RESPONSIBILITY:-
To manage activities of RMsection.
Provide leadership and direction to ensure the achievement of all RM section.
Timely release of In-process, Validation and Product samples.
To maintain SOPs related to finished product as per global quality standards and regulatory requirements.
To support QA systems and process related to data review.
To support regulatory operation for timely submission.
Responsible for laboratory investigation and root cause of OOS, OOT, deviation and implementation of CAPA accordingly.
Periodic review of related log books.
To ensure execution and review of protocols of calibration, mapping and qualification of stability chambers and other instruments.
Coordination for analytical method transfer and review of respective records.
Maintain and report quality matrices for commercial finish product and stability sections.
Monitor performance and set improvement areas.
Determine resource needs (staff, instruments, lab space etc.) and manage organizational development including interview and selection, mentoring, coaching, counselling and performance management of staff.
Testing of Raw Materials, Stability Sample and Finished products.
Recording the analytical data in raw data sheet/protocol.
Ensure standardization of working standards and conduct, preventive maintenance, calibration, qualification of laboratory instruments as and when required.
Ensure accuracy of document and maintain neat/concise/organized stability record.
Follow the EHS policy, Laboratory procedure and maintain the compliance to cGMP requirements.
Initiate the OOS, OOT and deviation & CAPA in Track wise software.
Destruction of RM/Finished Product/Stability/Validation/In-process/Swab samples after completion of analysis and review of the data.
Ensure integrity, accuracy and adequacy of the analysis performed.
Recording of instrument and standard usage in the respective log books/registers.
To perform the analytical method transfer activity.
Preparation of eCOA /SAP COA/ Regulatory COA as per requirement.
Participate in all internal, external and regulatory inspections.
Maintain cGMP compliance in the working areas.
To ensure qualification of analysts and competency matrices.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.