Ananth G

• Improved overall user experience through support, training, troubleshooting, improvements and communication of system changes.
• Quality Approver for QMS systems (Change control & Incidents/ Deviations, Investigations, Laboratory investigation and CAPA.
• Collaborated with developers for implementation of new software & applications in QMS platform to meet quality requirements.
• Trained new team members by relaying information on quality procedures.
• Adapted existing procedures to mitigate issues and improve deficiencies.
• Revised and drafted policies and procedures to address deficiencies comprehensively.
• Third party/ Supplier management.
• Liaised between Quality assurance and other departments and service providers, providing quality updates.
• Worked different stations to provide optimal coverage and meet production goals.
• Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
• Minimized resource and time losses by addressing employee or production issue directly and implementing timely solutions.
• Quality coordinator for Market complaint.
• User access management in 21 CFR systems/ equipments
• Review and Approval of IRA & ACPM documents.
• Ensure manufacturing equipments and associated software's are meets 21 CFR-Part11 compliance.
• Review and Approval of CSV documents.

QMS:

• Handling of QMS (Incidents, Investigations, CAPA, Change controls & PMSI ) for its Review adequacy and Approval.
• Identifying, assessing, reviewing, logging and approving of incidents / investigations from all departments in plant by using Track wise system.
• Coordinating with Global quality team on review of critical investigations and escalation of critical quality events on identification.
• Escalation of atypical events & critical quality events to management and applicable CFTs/ Tier 0/ Tier 1 Team.
• Handling and Participate in Internal audits and External audits.
• Representing as Quality Approver for Change control & Incidents/ Deviations, Investigations and CAPA.
• Quality coordinator for Market complaint.
• Third party management.

User access management in 21 CFR systems/ equipments &Training Management

• Support computer system validations in related stakeholder areas.
• Review and Approval of IRA & ACPM documents.
• Handling of User access management in 21 CFR equipments/ systems.
• Ensure manufacturing equipments and associated software's are meets 21 CFR-Part11 compliance.
• Review and Approval of CSV documents.
• Handling of User access management in manufacturing equipments and associated software's are meets 21 CFR-Part11 compliance.
• Review monthly/ Quarterly audit trail verification and Alarm challenge verification of critical equipments for accuracy, correctness and completeness.
• To co-ordinate annual training plan with Training coordinator on cGMP and technical aspects.
• Preparation of role details, Job description, Technical training induction training & MTRI for all employees within department.

Qualification & Validation:

• Review and approval of validation & Qualification protocols and reports of Equipments, Areas, & Utilities.

Track wise:

• Representing as Super user for site.
• Expert in Track wise systems.

System:

• Site Master File, Quality Manual preparation & revision based on requirement.
• Provide support to updates and review of SOPs & other GMP relevant documents of various functional sections.
• Pre & Post approval of Breakdowns related to Utilities & Laboratory equipments.
• Independent and self- starter. Performs well with minimal supervision.
• Identify and proactively surface quality issues to cross functional partners and provide recommendations and solutions.
• Developed procedure and protocol for COVID-19 pandemic situation.

IPQA :

• Handled and management for Quality Assurance activities about 7 different dosage formulations - Tablet, Capsule, Dry syrup, Soft Gel, Ointment, Liquid Orals and Dry Powder Injectable.
• Hands on performing in process quality assurance checks for Tablets, Capsules (Hard & Soft), Liquid orals, Dry syrup and Dry Powder Injectable.
• Assurance of Line clearance for Manufacturing Process and Final Packing of Drug product.
• Effective communicator & team player with strong logical, problem solving abilities.
• Reviewed of Batch Manufacturing Record/ Batch Packaging Record (Master/Filled).
• Reviewed validation Protocol for Process validation/ Cleaning validation/ CIP/ SIP validation, Disinfectant validation.
• Performed that all QA Tests are carried out on time and in full.
• Work with Production personnel in advisory role to assist them with quality issues within their department.
• Ensured GMP and regulatory compliance during manufacturing, packaging, testing & distribution by conducting audits, Documentation reviews and continuous follow ups.

IPQA :

• Prepared Standard Operating Procedures, Batch Manufacturing records and Batch packing records.
• Experienced in issuing of line clearance at every step of batch manufacturing in 9 different dosage formulations - Injections (SVP/ LVP), Tablet, Capsule, Dry syrup, Soft Gel, Ointment, Liquid Orals and Dry Powder Injectable.
• Participated in new process development and process optimization programs to enhance overall system capabilities