Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Area Of Expertise
Roles And Responsibilities
Personal Information
Professional Overview
Hobbies and Interests
Employment Recital
Projects
Training
Disclaimer
References
Certification
Timeline
Generic

Sohan Kumar S Mahale

Bangalore

Summary

Hardworking Quality Assurance Manager with extensive knowledge of API inspections to multitask effectively. Skilled at managing long-term quality goals and day-to-day organization. Successful at forecasting market trends and financial needs. Precise Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Quality Assurance Head

Hermes Laboratories Pvt. Ltd.
03.2014 - Current
  • Enhanced product quality by implementing comprehensive QA processes and procedures.
  • Reduced defects in products by conducting thorough inspections and identifying areas for improvement.
  • Led cross-functional teams to ensure seamless collaboration in achieving project goals.
  • Improved customer satisfaction ratings through meticulous attention to detail and consistent quality control measures.
  • Maintained a safe working environment by adhering to strict safety protocols and conducting regular inspections of laboratory equipment and facilities.
  • Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
  • Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization.
  • Managed supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
  • Championed continuous improvement initiatives, consistently seeking ways to optimize operations for better results.
  • Implemented corrective action plans based on audit findings, resulting in measurable improvements over time.
  • Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
  • Established robust quality documentation systems that ensured traceability throughout the entire production lifecycle.
  • Championed a customer-focused mindset across the organization by emphasizing the importance of consistently delivering high-quality products and services.
  • Performed root cause analysis to identify and resolve quality issues and defects.
  • Created and maintained quality management systems to align with industry standards.
  • Collaborated with cross-functional teams to develop and implement process and system improvements.
  • Implemented new quality assurance and customer service standards.
  • Investigated customer complaints and performed corrective actions to resolve quality issues.
  • Conducted risk assessments to identify and mitigate potential quality issues.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Specified quality requirements of raw materials with suppliers.
  • Collaborated with cross-functional teams to identify root causes of product issues, leading to timely resolutions and continuous improvements.
  • Optimized inventory management by tracking usage patterns of consumables, chemicals, and reagents in the lab, ensuring minimal waste and cost-effective purchasing decisions.
  • Provided training to new hires on proper laboratory techniques, equipment operation, safety protocols, and regulatory guidelines.
  • Reduced out-of-specification results by conducting thorough investigations into root causes and recommending effective corrective actions based on findings.
  • Facilitated timely completion of projects by managing multiple priorities simultaneously while maintaining high standards of accuracy and attention to detail.
  • Achieved consistent compliance with cGMP guidelines by maintaining a clean and organized laboratory workspace, participating in regular audits and inspections.
  • Enhanced team morale by fostering a collaborative work environment, offering assistance to colleagues when needed, and engaging in open communication for constructive feedback.
  • Successfully met tight deadlines under pressure while maintaining high quality standards in all laboratory tasks performed.
  • Calibrated and maintained laboratory spectrometers and chromatographs.
  • Collaborated with supervision, engineering and other personnel on quality and performance improvements.
  • Created spreadsheets and other forms of documentation to accurately record and calculate analytical results.
  • Enhanced product quality by performing routine testing and analysis of raw materials, intermediate products, and finished goods.
  • Assisted in troubleshooting production issues, effectively reducing downtime and improving overall productivity.
  • Examined inoperative or malfunctioning production equipment to diagnose source of trouble.
  • Modified and adapted standard methods and procedures to solve analytical problems.

Education

Bachelor of Engineering - Chemical Engineering

Dayananda Sagar College of Engineering
Bengaluru
01.2011

PUC - PCMC

Sheshadripuram Composite PU College (Department of Pre-University Education)
Bengaluru
01.2007

10th - 10th

Poornaprajna High School
Bengaluru
01.2005

Skills

  • Quality Systems
  • Knowledge of quality systems
  • Audit Coordination
  • Trend Analysis
  • Policy Reinforcement
  • Document Control
  • ISO Standards
  • Employee Training
  • Quality assurance background
  • Personnel Training
  • Employee Recruitment
  • Employee Supervision
  • Audit reporting
  • Continuous Improvement
  • Very good knowledge on Microsoft Excel, Microsoft Word & Power Point
  • Internal Audits
  • Risk Analysis and Mitigation
  • Work Planning and Prioritization
  • Attention to Detail
  • Quality Assurance Management
  • Documentation Review
  • Validation Techniques
  • Product Inspections
  • Specification Review
  • Process Documentation
  • Staff Supervision
  • Multitasking Abilities
  • Defect Identification
  • Problem-solving abilities
  • QMS
  • Human Resource Management

Accomplishments

  • Supervised team of 10 staff members.
  • Documented and resolved [Issue] which led to [Results].
  • Achieved [Result] through effectively helping with [Task].

Languages

English, Hindi, Kannada, Konkani.

Area Of Expertise

  • Quality management: Maintaining facility, production activity adherence to comply regulatory requirement. Preparation and maintaining of documents to comply regulatory requirement. Planning and execution for validation of facility/system/batches. Successfully comply with external audits like Biocon, Sigma Aldrich, Syngene and various vendors. Preparation, maintaining document and successfully audited for GMP guidelines.
  • Stores Management: Managing facility, managing raw material from entry till final documentation. Arrangement & handling of hazardous, non hazardous, corrosive & acidic material. Arrangement of materials for better handling & storage. All in all complete store management.
  • Man Management: Managing a team of production block. Training on SOP’s, equipment, safety, risk management & first aid to enhance performance and skill of others.
  • Regulatory Affairs: Ensuring that the companies comply with all of the regulations and laws pertaining to their business. Working with state and local regulatory agencies and personnel on specific issues affecting their business. Advising the companies on the regulatory aspects.

Roles And Responsibilities

  • Preparation & Issue of Batch Production Records, Master Formulae and Annexure to the respective departments.
  • Preparation, Distribution & Training on Standard Operating Procedures and Standard Test Procedures to the respective departments.
  • Control & Checking of the Batch Manufacturing Records.
  • Preparation & Filling report on failure investigations/ deviation/ Out of specifications (OOS)/ cleaning verification /validation/ handling of market complaints and all important procedures.
  • Conducting training programs as per the schedules provided.
  • Checking of the quality control, production and maintenance records.
  • Co-ordinate while carrying out investigation of complaints.
  • Co-ordinate with production / warehouse departments while carrying our investigation of returned goods.
  • Review of critical in-process test control and critical API test results.
  • Review of all critical deviations or non-conformances and related investigation.
  • Reviewing completed batch production and laboratory control records of critical process steps before release of the APIs intermediates for distribution/Release of finished product for dispatch to market.
  • Issue of necessary documents for finished product for dispatch to market.
  • Maintaining necessary documents after the dispatch of material.
  • Training program of employees.
  • Conducting internal audits. (self-inspections)
  • Investigating quality related complaints and resolving with a solution.
  • Allocation of coding system to raw materials, intermediates and finished products
  • Procurement of raw materials, Inventory / Inventory document maintenance & management of intermediates & finished product from issuance till completion of product.
  • Controlling flow & traceability of raw materials issued for the different batches.
  • Assuring quality of raw materials before issuing for the different batches.
  • Daily stock maintenance of raw material, intermediates & finished product.
  • Segregation of under quarantine, approved & rejected raw material, intermediates & finished product.
  • Preparing product validation.
  • Preparing shipping validation for products.
  • Central excise filing & documents maintaining of the same.
  • Labour office related documents.
  • Renewal & issuing of Factory License.
  • Export of materials related queries & documents. (Direct export, Indirect Exports to EOU & SEZ Units)
  • Renewal & issue of LUT Number for export of goods.
  • To follow Safety norms and adhere to company’s policy.

Personal Information

  • Father's Name: Suryakant P Mahale
  • Mother's Name: Sunitha Mahale
  • Date of Birth: 12/30/89
  • Gender: Male

Professional Overview

B.E. in Chemical Engineering with 11 years’ experience in bulk drug manufacturing. Hands on experience in quality assurance, production and maintaining documents of quality, production & store. Leading team and team building, achieving targets within stipulated norms of outputs, safety and quality. Inventory control and management. Preparation and maintain documents to comply regulatory requirement. Validation programs. Active participation and successfully accomplished of regulatory audits. Preparation and maintain documents to comply Sustainability requirement. Successfully completed Ecovadis audit with a score of 49% & “Committed” badge. Undergone customer audit several times with one from Japanese.

Hobbies and Interests

Philately

Employment Recital

  • Hermes Laboratories Pvt. Ltd., Q.A Head, 1.8 years and running
  • Hermes Laboratories Pvt. Ltd., Q.A Assistant, 2 years

Projects

Successfully completed project on extraction of Chromium from contaminated soil by using washing technology.

Training

  • Safety training by Shell India.
  • One day workshop on “Labour Laws”.

Disclaimer

I, Sohankumar S Mahale, declare that the above information is true and correct to the best of my knowledge and nothing has been concealed or distorted.

References

Will be provided on Request

Certification

  • ISO 9001 : 2015 Internal Audit course Training - 2 days

Timeline

Quality Assurance Head

Hermes Laboratories Pvt. Ltd.
03.2014 - Current

Bachelor of Engineering - Chemical Engineering

Dayananda Sagar College of Engineering

PUC - PCMC

Sheshadripuram Composite PU College (Department of Pre-University Education)

10th - 10th

Poornaprajna High School

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Sohan Kumar S Mahale