SHAJI - QUALITY CONTROL - SPIMACO

Summary

To prove myself as dedicated, worth full and energetic employee in a progressive organization that gives me scope to apply my knowledge and skills, and be a member of a team, which dynamically works towards my success and growth of the organization.

Overview

19

years of professional experience

5

Languages

Work History

Q.C ( TEAM LEAD & COMPLIANCE )

SPIMACO

11.2021 - Current

Presently, I am looking for planning and releasing raw materials, including APIs, excipients, and packaging materials, based on analytical data review.
Reviewed analytical data for raw materials and finished products to ensure compliance with quality standards.
Updated and maintained Quality Control Specifications and Methods (QCSM) for various materials.
Prepared gap analysis reports for new product development and regulatory submissions.
Reviewed and maintained Purified Water and WFI (Water for Injection) testing records.
Managed SAP system updates for material status and QC transactions.
Coordinated technology transfer from R&D to QC for analytical method implementation.
Reviewed analytical testing reports using LabWare LIMS (version 8.0).
Expert in HPLC and UPLC for troubleshooting, assay, related substances (RS), and dissolution (Disso) testing. Analysis of various formulated products, such as creams, syrups, ointments, solids, and oral suspensions, by using HPLC, UV, FTIR, ICP-OES, and dissolution instruments.
Preparation and Harmonizing the SOPs and Systems.
Reviewed and signed off the investigation summary reports for out-of-specifications, out-of-trend, incidents, and deviations.
Review of laboratory data integrity and periodic checks of HPLC for audit trials.
Initiate an incident and investigate when laboratory investigation findings are not conclusive.
Approving Phase 2 and Phase 3 laboratory actions, and ensuring laboratory actions are closed.
Method development for assay and dissolution by HPLC.
Review of analytical data of finished product, stability, and in-process validation analysis.
Technology transfer of analytical methods to QC, method verification, and test sample as per schedule.
Testing of all stability samples under different conditions at different intervals, as per ICH guidelines.
Preparing the stability study protocol and maintaining the inventory record.
To improve existing analytical methods and calibration of analytical instruments.
Monitor routine maintenance of modern analytical equipment such as HPLC, GC, ICP OES, UV, and IR.
To plan and execute the laboratory instruments' calibration, validation, and qualification as per GLP requirements.
To accomplish trials and experiments with scientific instruments, and to perform literature searches and reviews.
Review the laboratory instrument log, its maintenance log, equipment qualification reports, laboratory records, etc.
Maintain the highest standards of safety, health, environment, GMP, and GLP in the analytical laboratory.
Preparation of the STPs, Analytical Method Validation Reports, and Method Development Reports.
Record keeping, the experimental details, and updating the work report in the project management system.
Responsible for the documentation of data acquired from laboratory experiments, and presenting it in a group meeting.
Strictly adhere to industry standards to minimize the risks, and improve the throughput.
To prepare SOPs, protocols, COAs as and when required, and coordinate with the laboratory personnel to implement the laboratory's testing operations.
Established rigorous safety measures for high-stakes and potentially dangerous factory environments.
Advised and led process improvement team with deliberation, leadership and strategic planning.

QA VALIDATIONS-(TT-DEPT)

RIYADH PHARMA

06.2010 - 11.2015

QC-AR@D (SENIOR-EXECUTIVE)

VIVIMED LABS LIMITED

05.2010 - 06.2010

QC (CHEMIST-JR-EXECUTIVE)

SRIKRISHNA PHARMACEUTICALS

05.2007 - 04.2010

Education

Master of Science - Analytical Chemistry

Bharathidasan University

Tamilnadu, India

04-2006

Bachelor of Science - Mathematics, Physics and Chemistry

Nagarjuna University

Andhra Pradesh, India

04-2002

Skills

Chromatography:

HPLC (Water Alliance 2695) with Empower-3 Software

HPLC (Shamidzu) with Empower-3 Software and LC solutions

GC (Agilent) With Empower-2 Software and chromelon software

Inductively Coupled Plasma Optical Emission Spectrometer (ICP-OES) – PerkinElmer

SOR-Specific Optical Rotation-Jasco

Spectrophotometer:

UV Visible (Agilent) with Chemestation Software

TRAININGS/ACHIEVEMENTS

Work experience in Lab ware ERP and QMS.
Good Laboratory Practices.
Knowledge and exposure of cGMP, GLP and ISO-17025 guidelines and ICH – guidelines.

Declaration

I hear by declare that the above information and particulars are true and correct to the best of personnel knowledge and belief. Place

AUDITS FACED

WHO : World Health Organization – Facility Audit.
USFDA : United States Food and Drug Administration.
HACCP : Hazard analysis and Critical Control points.
FAMI-QS : Feed additives, functional feed ingredients, premixtures in Quality System.
SFDA : Saudi Food and Drug Administration.

Timeline