• Gender: Male
• Age: 54
• Designation: Senior Manager
• Highest Education Level: Masters - Degree
• Preferred Country: India
• Notice Period: 30  Days
• Work Experience: 29.4 Year(s)

Education

M.Sc (Chemistry) From Manonmanium Sundaranor University, Tirunelvel.

B.Sc (Chemistry) From Devanga Arts College, Arrupukottai, Madurai Kamaraj University.

Skill Sets

23 years in Medical Device, Pharma and Primary Packaging
(60 Dose Dry Powder Inhaler, Unit Dose Nasal Spray Liquid, Cranial Navigation, Spine Navigation, Insulin Pen, Vaginal Applicator, Vet. Syringe, Oral Dosing Syringe, Ophthalmic device, Eye drops (Pharma) made up of Rubber and Plastics).

Excellent Managerial Skills
Maintains Good Relations with Subordinates
Excellent Knowledge in handling MS Office Soft wares
Good Communication Skills
Excellent Trouble Shooting Skills.
Self Starter and have good motivation skills.

Integrated Management System From SGS,
Board - ISO 9001: 2008 , 14001: 2004 & OHSAS 18001 : 2007
Lead Auditor Course From TUV NORD Completed

Work Experience

Head – QA (Senior Manager): Present
Manager -QA: 4 Years
Company Profile : Manufacturer of Pharmaceutical packaging products, tablet packaging films, capsule packaging.
Job Profile
Notify Body: TUV-SUD
Key Skills: ISO13485: 2016, ISO:15378: 2015, ISO:14001: 2015 Implementation, CE Mark,ISO: 14644 Standard, ISO:11135, ISO:11137 and ISO: 11607.
Device: 60 Dose Dry Powder Inhaler, Unit Dose Nasal Spray, Vaginal Applicator, Veterinary Syringe, Vaginal Syringe, Implant Device and Primary. Packaging.

Manager -QA
4 Years 2 Months
Job Profile:
Notify Body: TUV SUD
Key Skills: CE Mark, USFDA, 510K submission, DMF, ISO 13485 implementation, ISO 15378, ISO 11135, ISO 11137, Clean room standard
Device: Insulin Pen, Safety Needle Device, Auto Injector, Dry Powder Inhaler and Oral Dosing System, Primary Packaging.

Senior Manager QA/QC/RA
Nov 2016 to Mar 2018
Company Profile : Manufacturer of Pharmaceutical Products.
Job Profile:
Notify Body: TUV
Key Skills: ISO13485: 2016 and CE Mark
Device: Eye Drops.

QC Manager
1 Year
Company Name: SISCO Latex Private Limited.
Job Profile:
Notify Body: DNV
Key Skills: ISO 13485, CE Mark, Clean room 14644, ISO:11135
Device: Foley Balloon Catheter

MR
1 years 6 months
Company Name: Appasamy Associates
Job Profile:
Notify Body: TUV SUD
Key Skills: ISO 13485, CE Mark, Clean room 14644, ISO:11135
Device: Surgical Blades, Surgical Instruments, Active Medical Device and Intra Ocular Lens, Eye drops.

Asst Manager -QA
15 years 2 months
Company Name: TTK –LIG Limited
Job Profile:
Notify Body: BSI
Key Skills: ISO 13485, USFDA, ISO 14001, ISO 18001, TPM, SAP
Device: Condom & Surgical Gloves.

Key account-abilities included:
Quality operations (shop floor management) and its compliance to all time inspection readiness and state of control ensuring regulatory approval status. Type III DMF submission for FDA and Type II DMF submission for Canada
Developing Quality system and simplified procedures in line with industry and Regulatory and statutory expectations.
Delivered and improved global standardized process for investigation, deviation and CAPA management and document process.
Monitor and report on regulatory compliance and site readiness activities within the GMP business segments.
Member of the business Quality Assurance management team responsible for creating and supporting a quality culture across site by driving compliance activities and integrating QMS account-abilities..
Leverage Industry best practices and improve policies to ensure regulatory compliance and cross site standardization for Training, visual Inspection, concession. Internal Audit, Investigations, CAPA and Document Change control.
Member of the CAPA Leadership strategy Team delivering investigation and CAPA Training and Qualifying Trainers to deliver a consistent approach to documenting and executing in depth investigations, CAPA and action plans.
Providing on site direction for site QMS to ensure compliance with CGMP, QSR, ISO for terminally sterilized and ascetically filled small volume filled parental, Large volume parental and medical devices of all Quality Assurance functions for Global manufacturing. Effectively lead FDA, GMP, ISO, MDD Compliance Inspection supported critical products development and process improvement projects impacting 510k, PMA, CE. Successfully implemented and directed the improvements to key Quality system (Change Management, CAPA, Deviation, Document Control, Training, vendor Management) resulting in real time monitoring of Quality information from all processes, work operations, concessions, Quality audits, quality records, complaints, Return products, Non conforming products, material attribute defects, root cause and Corrective / Preventive actions.
Effectively coached and mentioned key individual ensuring depth of knowledge relevant to quality goals and regulatory compliance.
Developing validation policies and programme management.
Technology transformers on time submissions and product launches.
Transfer of product from Developmental R & D to Production.
Proficiently functioned as Management Representative for ISO 13485: 2016.
Responsible for Planning and Conducting Management Review Meetings.
Risk Assessment for QMS process and Products as per ISO 14971: 2012.
Post Market Surveillance and Post Market follow up as per MDD.
ISO 10993 Biological Evaluation of Medical Devices follows up.
Well knowledge about sterilization ISO 11135 for ETO and ISO 11137 for Gamma.

Future Goals

Growth