Mukundan Venkatesh
Bengalore
Summary
Prologue 14 year 4 month of experience in Phyto Pharmaceutical Manufacturing & Solvent Cement plant. Worked in Quality Assurance department and quality control organizations having GMP and regulatory compliance. Willing to travel. Willing to relocate. Self-motivated, detail oriented, and good industrial and interpersonal skills. Highlighting Skills In-depth knowledge of manufacturing practices, GDP, GLP, Validation and procedures. Knowledge on ISO-9001, NSF-GMP, ISO-22000.ISO 18001 In-depth knowledge of quality control and quality assurance ,R&D ,F&D ,Stores & Production department Knowledge on QC-Instruments. Knowledge on physico-chemical analysis Ability to communicate effectively with all levels of staffs in a professional manner. Dependable, energetic, creative and resourceful. Strong troubleshooting and problem solving skill. Hardworking Quality Manager with talents in strategic planning, statistical process control and project management. Dedicated to ensuring improvements are implemented. Knowledge of data analytics and data management. Intelligent Quality Manager with talents in monitoring production quality and improving productivity. Deep understanding of the tools and concepts that go into quality management. Flexible, reliable and ensure standards meet expectations and legal compliance.
Overview
14
14
years of professional experience
Work History
PLANT QUALITY HEAD
ASHIRVAD PIPES SOLVENT PLANT
BENGALORE
01.2016 - Current
- Key Highlight:
- 1) Set up the Quality Control Laboratory. 2) Handling With Stores and Finished goods for set up Process and 5s Audit 3) Instillation of lab equipment’s 3) Development of New Methods
- 4) Product development and Product NSF Certification handling
- 5) BIS License handling 6) ISO Implementation and certification iso 9001,14001,45001 7) New Product specifications development and supplier identified
- 8) Packing design development.
- 9) Supplier Audit.
- 10 ) SAP implementation.
- 10 ) Overall Plant Quality head.
- Effective handling like Gas Chromatography, Brookfield viscometer, FT-IR Spectrometer & Explosion proof oven all solvent and solvent cement testing related equipment’s etc.
- ASTM-F493 AND ASTM D 2564 Standard handling
- IS -14812 Standard handling
- Knowledge of solvents usage & Expertise in handling as per safety norms
- Capability with failure analysis, accident investigation ,testing
- R&D Product development
- Experience in handling R&D as per process requirements
- Analysis of packing material, Raw Material, Intermitted Products & Finished product
- Reports release
- Customer complaints handling
- Manage with Quality control & Quality Assurance department
- Validation for Product, process, and Equipment’s
- Specification developing for packing Material, Raw material & Finished Products
- To prepared the process sop and documentation and release the control copy
- To conduct the internal audit as per schedule
- To conduct the MRM and closed the non-Conformance reports
- Product MSDS development
- Product technical data bullet points development
- Supplier audit as per schedule
- Supplier identified and cost saving the Raw Material and Packing Material
- Distributors and dealer visit every month for Product feedback
- Training conduct all plant Peoples Production, stores, QC and maintenance
- Very Depth knowledge Process like SCM, production, Stores and Purchase and customer requirements
- Quick Action for RCA and customer requirements
- Costing saving Project handling with Process
- Process development and simply system
- 5S System implementation
- Rejection control and fixed the target every month
- Continues Improvement Project
- Product Benchmark study
- Product Stability study
- THF & Cyclohexanone free solvent cement product project study.
- Managed team of quality assurance professionals responsible for ensuring product safety and reliability.
- Coordinated training sessions for personnel involved in Quality Assurance activities.
- Collaborated with cross-functional teams to ensure that all processes are compliant with relevant regulations.
- Maintained records of nonconformances, corrective actions taken, customer complaints.
Quality
NATURAL REMEDIES (P) Ltd
03.2013 - 01.2016
- JOBPROFILE: QUALITY ASSURANCE
- Pharmaceutical Manufacturing
- Key Highlight: 1) Identified Process error
- 2) Improve the product Yield 3) control the Batch failure
- Did In-process checking and sampling of Intermediate, Bulk Finished and Finished Product
- Reviewed BMR and BPR and did final release of batches for distribution
- Document issuance and retrieval including BMR, SOPs, and other controlled documents
- Actively participated in Process validation, execution of validation
- Root cause analysis of Quality related issue and Implementation of CAPA (Corrective and Preventive Action) through proper documentation
- Evaluation and Closure of Deviation with proper documentation
- Investigation of Incidence and implementation of the corrective actions
- Imparting Self Inspection
- Assuring GMP compliance on Shop floor by solving product related issue and proper co-ordination with other departments for smooth functioning of system
- Planning, co-ordination and conducting training program on GMP topics as well as on job SOPs training as per training schedule and Calendar
- Ensuring periodic validation and Re-Validation related to process and Equipment’s/Instruments whenever required
- Assisted with department head in developing Systems, SOPs and documents as per GMP requirements
- Ensured optimum productivity in term of work in the department
- Monitoring production process and process controls
- Implementation and educating the employers on HACCP
- Preparation of Cleaning Validation Protocols and Reviewing of Cleaning Validation Reports
- Follow up the External Auditors points and Implementations
- Daily audits to other departments
- Preparing of Monthly Reports
- Investigation of Deviation and raising the CAPA, Implementation of Change control and Review of Reprocess & Rework documents
- Implementation of company’s Quality policy and GMP Regulations at site
- Overall monitoring of quality activities in the area of operation
- Coordinating with team members for achieving quality requirements
Quality Control
NATURAL REMEDIES (P) Ltd
05.2009 - 03.2013
- Key Highlight: 1) Manufacturing unit lab set up, 2) Manage with Quality Control Department
- Physical observation of herbal RM Immediately after receipt ,Sampling of oils /solvents /in processed materials and micro sampling for production area
- Analysis of raw materials /solvents /oils/in –processed materials ,chemicals
- Ensuring sampling is done with in specified time of receipt of requisition
- Monitoring reports released within timelines
- Sampling of packing materials and analysis
- On time release of reports is >90%
- Reduction in numbers of repeated complaints from internal and External customers
- Ensuring accurate analysis
- SOP Preparation
- External & Internals audits facing
- Instruments handling
- Weighting balance
- PH Meter
- KF -Titration
- Hardness meter
- Sieve analyzer
- HPTLC
- HPLC
- UV
- Photo documentation
- GC
Education
Msc - chemistry
Periyar University
01.2017
B.SC - BCZGT
Governments science college
05.2008
Higher Secondary -
Government higher Secondary school
03.2005
Skills
1) Set up the Quality Control Laboratory
2) Handling With Stores and Finished goods for set up Process and 5s Audit
3) Instillation of lab equipment’s
4) Development of New Methods
5) Product development and Product NSF Certification handling
6) BIS License handling
7) ISO Implementation and certification iso 9001,14001,45001
8) New Product specifications development and supplier identified
9) Packing design development
10) Supplier Audit
Languages
Timeline
PLANT QUALITY HEAD
ASHIRVAD PIPES SOLVENT PLANT
01.2016 - Current
Quality
NATURAL REMEDIES (P) Ltd
03.2013 - 01.2016
Quality Control
NATURAL REMEDIES (P) Ltd
05.2009 - 03.2013
Msc - chemistry
Periyar University
B.SC - BCZGT
Governments science college
Higher Secondary -
Government higher Secondary school
Similar Profiles
Thenmozhi KuppusamyThenmozhi Kuppusamy
Senior Executive – HR at Ashirvad Pipes Pvt LtdSenior Executive – HR at Ashirvad Pipes Pvt Ltd
Kirti Ranjan SinghKirti Ranjan Singh
Terrritory Growth Manger at Ashirvad Pipes Pvt..ltd.Terrritory Growth Manger at Ashirvad Pipes Pvt..ltd.
Prakash TripathiPrakash Tripathi
Vice President Plumbing Retail at Ashirvad Pipes Private LimitedVice President Plumbing Retail at Ashirvad Pipes Private Limited