LALMOHAN G K

To pursue a challenging career in the pharmaceutical field and achieve a good position in a professionally managed organization where my education skills, experience and knowledge are best utilized for the growth of the organization I work with.

To perform the reviewing of pharmaceutical products following CGMP, GLP and corporate policies and Work either independently or as a team to achieve company goals and initiatives.

• Working as a Raw material and GLP team Section-Head.
• Previously I handled stability, Finished product, In process sections.
• Raw material samples analysis planning, review, and approval of the Raw materials. Key raw material vendor qualifications.
• Working standards and in-house reference standards qualification planning as per schedule.
• Working standard qualifications against with pharmacopeial standards.
• Working standard COA’S preparation & approvals.
• Standards consumption &Destruction records maintaining.
• Preparation of Preventive maintenance, Internal calibration &External calibration schedules as per the Quality control procedures.
• Analytical instruments calibration planning as per schedule dates.
• Analytical instruments qualifications.
• Software qualifications as per GAMP5
• New joiners training and Analyst qualification planning.
• Review of Finished products, Stability, Raw materials, intermediates, in process samples.
• Review of HPLC and GC online sequences and electronically submitted sequences.
• Approval of analytical results in ERP (Enterprises resource planning and management)
• Analytical instruments audit trail review.
• Coordination of Internal and External audits.
• Good Knowledge about ICH Guidelines
• Handling of Quality management system-Incidents, OOS,OOT, Change controls & Deviations.
• Document review and co-ordination with All department.
• Follow up the GLP practice and conduct the continued training programs to the chemist.
• Follow up the SOPs and STPs and review those SOPs based on CGMP requirements.

• HPLC: Agilent 1200&1260 infinity II series model, Shimadzu:LC-2010CHT.
• Software: Open lab CDS 2.7, Ezchrome, Chrome Leon &LC solution.
• GC&GC-HS: PerkinElmer, Agilent 7890A,7890B, Shimadzu 2014 model.
• Software: Open lab CDS 2.7, Ezchrome, Chrome Leon, GC solution, TCWS.
• U.V. Spectrophotometer: Shimazdu- Software: UV probe.
• FTIR: Spectrum-Two -Software: Spectrum.
• Polari Meter: - Rudolph & Jasco P-2000-Software: Spectra manager.
• Auto titrator: Metrohm - Software: Tiamo 2.3
• XRPD (X-Ray powder diffractometer), Make-Rigaku, Model-Miniflex II
• PSA (Particle size analyzer): Malvern-Software: Mastersizer3000.
• DSC&TGA: PerkinElmer, Software: Pyris

I hereby declare that the above information is true and correct to the best of my knowledge.

Place:

Date: (G.K.LAL MOHAN)