Highlights:Appreciation from top management in Orchid Healthcare, Actavis Pharma & Vivimed Life Sciences.

Skills:Supplier Audit,, Validation, Audit Trail, IPQA, Documentation, Market Complaints

Goal:To become a familiar person in Pharmaceutical Industry by establishing robust Quality Systems.

Membership:Registered Pharmacist – Tamilnadu Pharmacy Council, India (Certificate Number: 7158A1).

Certification:Registered Pharmacist – Tamilnadu Pharmacy Council, India (Certificate Number: 7158A1). Chromatographic Analysis (Gas Chromatography) at Advanced Training Institute, Government of India, Chennai. Data Integrity: Overview and Documentation Completion, Review and Approval by NSF.

Honor:College first among our batch during Master of Pharmacy and Bachelor of Pharmacy.

Senior Manager 01/2016 - current
Mylan Pharmaceuticals Private Limited, Hyderabad, Telangana India
Industry: Pharmaceutical Industry
Senior Manager – Global Operations Auditor Qualification of vendors of API, Excipients, Packaging Material manufacturers, contract manufacturer of dosage forms (Tablets, Capsules, Injectables and Oral liquid dosage forms).
Perform GXP audits based on a defined audit plan within specific time constraints. Prepare associated documentation including audit plans, audit reports and upload in TrackWise. Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards. Assess submitted audit response and associated Corrective Actions and Preventive Actions (CAPA) for appropriateness and adequacy. Manage existing suppliers in terms of periodic assessments and Quality Agreement maintenance. Facilitate opening and closing audit meetings with all levels of management. Report on audit status, supplier issues to management, including the highlighting of areas/suppliers that require further action to be taken. Coordinate with the Purchasing team on new supplier introduction and approval.--
Manager - Audit & Compliance 09/2014 - 01/2016
DR. REDDY’S LABORATORIES LTD., HYDERABAD, Hyderabad, Telangana India
Industry: Pharmaceutical Industry
Qualification of Vendors of API manufacturers. Ensure compliance to internal sites of Dr. Reddy's by carrying out Self Inspection.
Perform GXP audits based on a defined audit plan within specific time constraints. Prepare associated documentation including audit plans, audit reports and upload in TrackWise. Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards. Assess submitted audit response and associated Corrective Actions and Preventive Actions (CAPA) for appropriateness and adequacy. Manage existing suppliers in terms of periodic assessments and Quality Agreement maintenance. Facilitate opening and closing audit meetings with all levels of management.--
Manager - Quality Assurance 08/2011 - 09/2014
Vivimed Labs (Alathur) Private Limited, Chennai, Tamilnadu India
Industry: Pharmaceutical Industry
Head of Quality Assurance. Batch Release, Audit Trail, IPQA, Documentation & Quality Systems.
Ensure, implement and monitor quality system in place meets regulatory requirements and industry standards. Prepare, track and conduct internal and external audits. Follow-up with respective department / site for closure of audit observations and ensure appropriate CAPA are implemented. Handling IPQA team and responsible for ensuring cGMP compliance in shop floor. Batch Release and co-ordination with customers in final distribution of finished goods by providing documents / data as required. Handling market complaints. Deviation handling and CAPA management. Initiate risk assessment at appropriate stages. Performing audit trail for Quality Control Instruments as part of Self Inspection. Review and approve GMP documents such as master and executed batch records, validation protocols and reports (Process, cleaning and equipment qualification), SOPs, and change controls to ensure compliance. Review and approval of Site Master File, Validation Master Plan and Quality Manual. Review and approval of annual product quality review. Identifying potential issues & escalating to site Quality Head for timely action. Participating in Regulatory / Customer Audits and co-coordinating with the all the concerned departments for response compliance as part remediation. To impart training on to new and existing personnel. Planning for training gaps identification and training calendar. Experience in handling Quality Systems in QUMAS, AERS, Trackwise and SAP.--
Assistant Manager - QA 04/2010 - 08/2011
DR. REDDY’S LABORATORIES LTD., HYDERABAD, Hyderabad, Telangana India
Industry: Pharmaceutical Industry
Developmental (R&D) QA
Ensure, implement and monitor quality system in place meets regulatory requirements and industry standards. Prepare, track and conduct internal and external audits. Follow-up with respective department / site for closure of audit observations and ensure appropriate CAPA are implemented. Deviation handling and CAPA management. Initiate risk assessment at appropriate stages. Review and approve GMP documents such as master and executed batch records, validation protocols and reports (Process, cleaning and equipment qualification), product development reports, analytical method validation reports, SOPs, and change controls to ensure compliance. Review and approval of Site Master File, Validation Master Plan and Quality Manual. Identifying potential issues & escalating to site Quality Head for timely action. Participating in Regulatory / Customer Audits and co-coordinating with the all the concerned departments for response compliance as part remediation. To impart training on to new and existing personnel. Planning for training gaps identification and training calendar. Experience in handling Quality Systems in SAP.--
Senior Executive 08/2007 - 03/2010
Actavis Pharma Manufacturing Private Limited, Chennai, Tamilnadu India
Industry: Pharmaceutical Industry
Validation (Equipment, Process & Cleaning)
Ensuring cGMP compliance by in-process checks during batch manufacturing in shop floor. Co-ordination for batch release in final distribution of finished goods by providing documents / data as required. Prepare, review and execute GMP documents such as validation protocols and reports (Process, cleaning and equipment qualification). Handling of Market complaints.--
Executive Quality Assurance 11/2005 - 08/2007
Orchid Healthcare Limited, Chennai, Tamilnadu India
Industry: Pharmaceutical Industry
IPQA Activities
Carryout In-process checks during manufacturing. Carryout sampling activities during batch manufacturing. Stability management (Loading and withdrawal of sample) and compilation of stability summary report. Preparation of APQR/PQR.--

Annamalai University 07/1998 - 06/2002
Chidambaram, Tamilnadu, India
Degree: Bachelor's Degree
Major:Pharmacy
Bachelor of Pharmacy. University topper in the batch (1998-2002 year).

Suresh Chandran, QA Supplier Audit, Audit Trail, IPQA, Validation and Documentation