Quality Assurance Manager
Resume:
Curriculum Vitae
Kedar S. Waykul
Parsik Nagar, Old Mumbai – Pune Road,
Kalwe, Thane West, Maharashtra, India
Contact No: 095********/099********
Home: 081********
E-mail: ********@**********.***
Career path (Total experience: ~ 10 years 7 months in Quality Assurance)
Aug 2015- Till Date
Oct’ 2014 – Aug2015
Feb’ 2010 – Sep’ 2014
Assistant Manager- QA, Johnson & Johnson (Mumbai)
Deputy Manager- Quality compliance & audits, Deloitte (Mumbai)
Assistant manager – Quality Assurance, Sandoz (Thane)
Dec’ 2006 – Feb’ 2010
Sr. Officer – Quality Assurance, Watson (Goa)
Sep’ 2005 – Dec’ 2006
Officer- Quality Assurance, Cipla (Goa)
Almost a decade of experience in QMS, GMP gap assessment, Validations, Investigations, Audit & compliance.
Audit Faced: USFDA, EU, MHRA, WHO, Brazil Anvisa and several Health authorities of ROW countries.
Johnson & Johnson (Aug 2014- Till date) Assistant manager- QA
Work Profile:
Leading Overall Quality & Compliance department for J&J, Mulund, India
Deloitte (Oct’ 2014- Aug 2015) Deputy Manager – Quality compliance & audits
Work Profile:
Supporting pharmaceutical manufacturing facilities to manage global compliance obligations & tackle the fraud risk.
Gap assessment for GxP in accordance with current industry standards and regulatory guidelines.
Proactive & reactive support services to non sterile manufacturing facilities.
Compliance due diligence during pharmaceutical manufacturing facility acquisition.
Sandoz Pvt. Ltd, Thane (Feb’ 2010 – Sep’ 2014) Assistant Manager – Quality Assurance
Work Profile:
Site quality council presentation to management in order to take a glance on status of Quality indicators, departmental progress and thereby to identify area for improvement. Continuous monitoring to ensure for no overdue OOS, change controls, deviations and CAPAs. Propose & implement plans for continual quality system improvement thereby.
Gap assessment in line with regulatory guidelines/site quality modules and ensure implementation of current regulatory standards at manufacturing facility.
Prepration and updation of site master file and Validation master plan.
Assist a group of professionals allocated for validation activities and maintain site in the validated state as per Validation master Plan.
Cleaning process designing and ensure the effectiveness of established cleaning procedure with systematic validation studies, CEHT, DEHT & campaign length evaluation. Timely support production function by initiating risk assessment, matrix and bracketing, worst case evaluation and cleaning validation scheduling. Identified as a SME for cleaning validation at Sandoz.
Implemented approach with systematic documentation for packaging process validation. Enhanced productivity and process performance by establishing critical process parameters & machine settings ranges.
Coordination with validation lead to harmonise validation aspects within the sites in accordance with current regulatory expectations on process & cleaning validation activities.
Participating in departmental meetings and discussions to enhance product/ process understanding, failure investigations & execute validation activity smoothly.
Coordination, review/approval of several complaint & deviation investigation. Providing technical inputs during investigation process to facilitate decision in order to timely closure of relevant documents. Undergone rapid root cause investigation workshop & identified as a certified investigator.
Coordination for CAPA implementation and tracking to ensure for its effectiveness. Periodic meetings with key stakeholders to implement CAPA effectively.
Site support for licensing activity (Export/import/test licence/DCGI permission etc.) and Artwork verification as per D and C act.
Actively participated in various Health authority inspections. Preparation of audit outcome report, escalation of critical observations to management & interaction with key stakeholders to ensure corrective actions to bring observations to closure.
Preparation/review of standard operating procedures (SOP’s) & conducting trainings
Watson Pvt. Ltd, Goa (Dec 2006 – Feb 2010) Senior officer – Quality Assurance
Work Profile:
Preparation/review of standard operating procedures (SOP’s) & conducting trainings.
Review and approval of Deviations, Change control, Market complaints, Quality risk management documents.
Lead shop floor investigations to identify most probable root cause & contributing factors. Comprehensive investigation report prepration.
Review of analytical reports, method validation, stability study protocol & reports.
Conducted internal audits in manufacturing and warehouse area. Assist for vendor qualification activity.
Managed a team of 10 IPQA experts to ensure GMP compliance and provide shop floor support such as line clearance, in-process checks at manufacturing/packaging operations, online documentation review, sampling etc.
Compiling Annual product review & propose CAPA for identified improvement areas.
Involved in Intermediate product, raw and packaging material, cleaning samples releases by ensuring the compliance against the acceptance criteria & good documentation practices.
Review of various documents like batch records, technology transfer documents, validation protocol and reports etc.
Temperature excursion and Thermal cycling study implementation with systematic documentation & execution.
SAP R/3 system handled for product releases, Batch record issuance, COA checking, Vendor qualification tracking etc.
Unit VI (Oncocare) Cipla, Goa (Sep 2005 – Dec 2006) Officer, Quality Assurance
Work profile:
Quality risk management
Document review - MBR’s /BMR’s, BPR’s, SOP’s, Validation protocol &reports.
Taken care of documentation cell in order to archive & retrieval of documents in systematic & timely manner.
Audit & compliance.-Internal & regulatory inspection, corrective actions tracking for timely closure.
Deviation/ complaint handling. Review of investigation to ensure appropriateness & follow up for CAPA closure.
Cleaning validation (SOP’s, matrix & bracketing, Worst case identification, sampling & validation execution)
In process quality assurance (Line clearance, in process checks at manufacturing/packaging operations, sampling, product investigations & non routine validations etc.)
Process validation & QRA.
EDUCATION QUALIFICATION
Bachelor in pharmacy from Bharathi Vidyapeeth College of pharmacy (Shivaji University, Kolhapur)-First class
PERSONAL DETAILS
Permanent Address Date of Birth: 18th March 1984
56 ‘B’ G- 6
Kurtarkar Shrishti, Kurtarkar Nagari, Ponda, Goa, India
Nationality
:
Indian
Religion
:
Hindu
Marital Status
:
Married
Sex
:
Male
Languages Known
:
English, Hindi and Marathi
Hobbies
:
Dancing, Listening to music, travelling
Other features
:
Leadership potential, Creativity, Positive attitude, Communication and presentation skills
Reference:
Mr. Kailash Nale Dr. Sunit Padgaonkar
GM QA- Actavis, Goa Head QA, Sandoz,Kalwa
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