Santhosh Babu

M. PHARMA & 18 YEARS EXPERIENCE IN QA AT STERILE & NON STERILE FORMULATIONS. To be specialist in Quality Assurance, who can make qualitative Difference with an esteemed organization, where high competence and skill is rewarded equally for the mutual benefit of the organization and self.

DY. MANAGER - Bactolac Nutraceuticals Pvt Limited - Jadcherla, Formulation Division, Hyderabad, India

(2026-01)

• Responsible for overall compliance of the Quality at Bactolac Nutaceuticals.
• Responsible for review and approval of Qualifications of HVAC, Equipment and Calibration of Instruments.
• Responsible for review and approval of Temperature sesnor, Difference Pressure, Pressure guages.
• I am part of the vendor audit management team and perform vendor audits in a timely manner based on the requirements.
• Ensure performance of self Inspection/ Internal audits (Internal, External, Customer, Visits, and Regulatory)and assist with external quality system audits including taking a leadership role in addressing supplier quality issues.

ASST. MANAGER - Granules India Limited - Gagillapur, Formulation Division, Hyderabad, India

(2012-01 - 2025-12)

• Participating as a representative of the Operational QA team (Approx. Team Size: 15 Members) to assist the different areas of QA functions. Implementation of GMP and GLP at workplace.
• Responsible for ensuring timely readiness at the manufacturing site. This is done by carrying out routine technical aspects to ensure compliance with international regulatory bodies.
• Control on Batch Release System. i.e. assembling and review of all documentation related to the processing & packaging and testing of each batch of the product before authorizing for sale.
• Taking care of SAP related activities like in process finish product sample details entry.
• Play an important role on handing of Market Complaints (US, UK, ROW) and investigation for its compliance (Minor, Major, Critical) including implementation & effectiveness of CAPAs.
• Ensure performance of self Inspection/ Internal audits (Internal, External, Customer, Visits, and Regulatory)and assist with external quality system audits including taking a leadership role in addressing supplier quality issues.
• Risk Assessment preparation, review and approval.
• Incestigate Incidents, OOS, OOT and Non-compliences.
• Handling of Quality Notifications like Deviations, Change Controls and its related Documents.
• Knowledge of Audit Trails, access controls, and system security.
• Experience with Data Integrity remediation and assessments.
• Providning Trainings to new joinees and Management of periodic trainings in LMS (Learning Management Syatem), Conducting cGMP classroom training.
• Map out annual training plans for management, HR, customer support and more.
• Design and develop training programs (outsourced and/or in-house).
• Elect appropriate training methods or activities (e.g. mentoring, on-the-job training, professional development classes).
• Market available training to employees and provide necessary information about sessions.
• Maintain updated curriculum database and training records.
• Host train-the-trainer sessions for internal subject matter experts.
• Manage and maintain in-house training facilities and equipment.
• Gather feedback from trainers and trainees after each educational session.
• Review of (URS) user requirement specification and user acceptance testing for intended software applications.
• Project handled from initiation to Go-Live at sites of Learning Management and Quality management syste.
• Review & Perform risk assessments such as initial risk assessments, Functional risk assessments, GAMP categorization, GxP assessment, 21 CFR Part 11 assessment.
• Preparation of Validation plan and Review of all CSV deliverables.
• Review of Functional specification and Configurational specification.
• Preparation and Review of validation protocols such as IQ, OQ, and PQ and Execution of approved OQ test scripts.
• Preparation of traceability matrix and validation summary report
• Ensuring of vendor assessment.
• Reviewing Test scripts/Qualification.
• Audit trail verification for all the application as per specifications.
• Back up and restoration verification to all enterprise applications as per standards.
• Able to resolve the issues relevant to the applications as a trouble shooter.
• Coordinate with the IT team to install software and/or hardware and to implement changes in them when required.
• Coordinate the activities of deliverables with cross functional departments like project validation plan, standard operating procedures, Traceability Matrix, project validation summary reports, change control, incident management, corrective and preventive actions to establish/maintain validated systems.
• Review of periodic Review Plans.
• Effectively implementing QAMS application life cycle of computerized systems change control, deviations & CAPA and Good manufacturing practice.
• Well verse of knowledge in reviewing qualification documents in Labware (QC) instruments like HPLC, UV, KF Titrator etc.
• Led successful implementation of Computer System Validation (CSV) applications like Training Management System (TMS), Document Management System (DMS), and Quality Management System (QMS) across sites.
• Spearhead CSV activities (FS/DS/CS, test scripts, IQ/OQ/PQ) ensuring compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ and GxP.
• Good Knowledge and Understanding of Regulatory Guidelines like 21 CFR part 11Compliance, Eudralex Annexure 11,GAMP 5 etc., and accordingly training to new joiners as well as existing colleagues on “Computer System Validation” procedures. Supervising and guiding team of juniors in performing assigned tasks.
• Perform Backup, Archival and Restoration of Manufacturing and Laboratory computerized systems.
• Deployment of SAP S/4 HANA version 2021 and Minitab software version 2021 in various manufacturing units.
• Assessment of worst case Molecule
• Preparation of Cleaning Validation Protocol and compilation of cleanig validation report.
• MACO calculation for defining acceptance criteria (TD Based, LD50 Based and ADE/PDE Based)
• Co-ordination with CFTs for execution of Cleaning Validation activities.
• Maintaining cleaning validation Matrix and updating the same in-case of new product introduction at site.
• Determination of worst case location for each equipment as a part of cleaning validation assessment.
• Responsible for validation activities including process validation, cleaning validation, Hold time study
• Oversaw environmental monitoring and media fill validation activities in sterile areas.

MANAGEMENT STAFF - Cipla Ltd - Baddi & Sikkim, Formulation Division, India

(2010-03 - 2012-01)

EXECUTIVE - Pinnacle Life Science Pvt. Ltd. (Aarthi drugs Ltd) - Baddi, Himachal Pradesh, India

(2008-04 - 2010-03)

M.Pharma - PES college of Pharmacy, Bangalore