A K Benjamin

• Spearhead the commercial quality management and contract manufacturing operations (CMO) of Medical devices, Cardiovascular and Dermatological projects
  across Europe, and ROW markets and facilitate regulatory approval of in-licensed drugs.
• Contributed strategic support for commercial projects, including facility acquisition, sourcing & qualification of potential manufacturers, resource planning, monitoring trends of global sales & distribution, and working on pain areas.
• Coordinated with CMOs to drive QMS, documentation process review/approval, customer complaints, manufacturing process, addressing opportunities of improvements.
• Promoted effective quality principles at Commercial Affiliates while minimizing cost and potential disruptions to business and Coordinate activities between CMOs, and distribution centers as necessary to ensure policy requirements are met with respect to field actions.
• Advised management of compliance status and risk and Oversee fulfillment of GDP compliance with global supply chain operation for APIs and finished goods in Europe and ROW markets (North America, Australia, China, Pakistan, South Korea, and Turkey).
• Achieved 12% cost-saving in total logistics expenses by effective alignment of manufacturing planning and capacity with logistics management.
• Established the new supply chain network from Europe to the UK on-behalf of Brexit regulations.
• Appreciated for ensuring “Zero Stock-out” occurrence in market supply with the relevant stakeholders in Europe and the ROW market.
• Recognized for applying due diligence in acquiring a medical device facility in Europe at 23% of the reduced cost from the projected quote.
• Appreciated for identifying risk, and pain areas in manufacturing and market supply and developing a mitigation plan and implementing corrective
  measures.

• Provided leadership and quality oversight for consumer healthcare manufacturing facility, QA/QC functions, packaging, distribution, product commercialization and release of oral care and personal care (FMCG) ranges for domestic & GCC.
• Spearheaded end-to-end inspection readiness program, response to observation, implementation of CAPAs, fulfilling the compliance of ISO13485 (medical device), ISO9001, ISO22716 and ISO17025 requirements.
• Overseen specifications of RM, SFG, FG, and Packing materials, review/approval of SOPs, STPs, ROAs, MSDS, COAs of QC assignments, on-time batch release and regulations.
• Overall quality management system performance, monitoring Stability studies, Data Integrity & ALCOA compliance, Vendor management, Investigations, HALAL, HACCP, Process & Cleaning validation, and equipment lifecycle management.
• Strategized periodical evaluation of analytical practices, trends, challenges, risk assessment programs, and mitigation plans.
  Secured approval from MOH-UAE and acquired manufacturing license for medical devices in GSK’s UAE facility and achieved commercial take-off of new medical device variants (14 SKUs) in UAE & GCC.
• Optimized the key functions between stakeholders to ensure operations are keeping up with TAT and meeting the customer's expectations.
• Recognized for obtaining a 4-star rating of the site by GSK Corporate for achieving compliance with regulatory & quality standards.
• Achieved 100% of customer retention by enhancing customer satisfaction levels by optimizing QA and manufacturing process.
  Appreciated for built food manufacturing facility and contributed due diligence for ensuring compliance with Food safety (ISO22000) requirements

• Deviation management through electronic Discrepancy Management System

• Investigation-Quality & Compliance

• Discrepancy & Change management and Investigation

• Corrective & Preventive action management

• Periodical Quality Review meeting & GEMBA interaction for Lean Daily Management & Data integrity management

• Training – SOPs, GDPs, GLPs, GMPs & Audit & Compliance

• Data integrity monitoring & non-compliance management

• System upgradation as per regulatory guidelines

• Life cycle management of Site Master File

• Evaluation of investigations, Change management & trend preparation

• Review of testing procedures of microbial analysis

• Co-ordinating microbiology failures or incidents & CAPA management

• Implemented new quality assurance and customer service standards.
• Established and tracked quality department goals and objectives.
• Collaborated with cross-functional teams to develop and implement process and system improvements.
• Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
• Investigated customer complaints and performed corrective actions to resolve quality issues.
• Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.

• Spearheaded team of 7 members for microbial analytics on product testing

• Sterility testing, BET, Bioburden & EM

• Investigation of non-conformance

• Monitoring assay performance & Investigation-OOS/OOL/OOT

• Systemic review & procedure simplification

• Regulatory & Customer audits

• Audit preparation & Compliance management

• Ensuring SLA parameters for timely batch release

• Inventories management

• Creating SOPs, STPs and ROAs

• Calibration and Preventive maintenance

• Qualification of vendors & consumables

• Procedure simplification

• Environmental monitoring & failure investigation

• Performance review

• Establishment of rapid microbiology analytics-Sterility & BET

• Demonstrated creativity and resourcefulness through the development of innovative solutions.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Organized and detail-oriented with a strong work ethic.
• Strengthened communication skills through regular interactions with others.
• Managed time efficiently in order to complete all tasks within deadlines.
• Self-motivated, with a strong sense of personal responsibility.
• Proven ability to learn quickly and adapt to new situations.
• Proved successful working within tight deadlines and a fast-paced environment.
• Gained extensive knowledge in data entry, analysis and reporting.

• Spearheaded team of 5 members for QC microbial analytics of pre & probiotics

• Optimization of resource utilization through task allocation to team members

• Identification, isolation & characterization of probiotic strains from various sources

• Procurement of raw-material and execution of blending plan as per customer’s specification

• Management of deviations, OOS,OOL,OOT and customer queries

• Drafting, review and approval of SOPs followed by implementation of system as per guidelines

• Ensuring periodical reporting on progress of development, analytical trends, deviation addressal, change management, CAPAs and compliance reports pertaining to probiotic department to the top level authorities of the company

• Facilitating training sessions for team members on SOP, GLP & GMP

• Probiotic analytics and strain based identification cum RT-PCR based quantitation of probiotics.

 M Sc. (Microbiology), 79%, Madurai Kamaraj University (2003)

 B Sc. (Microbiology), 79%, Madurai Kamaraj University (2001)