Quality Assurance Management

SANKET KU MAR PATRA

Mobile: +91-900******* / +91-993*******

Email: ******.*****@*****.***

O BJECT IVE

To toil for any progressive organization that provides opportunity to utilize my skills and knowledge

for the benefit of the company & which provide scope for my career improvement in Quality

M anagement Systems.

E DUCAT ION

• 2013, M. Pharm. in Pharmaceutical TQM; Kuvempu University, Karnataka; F irst class

• 2005, B. Pharm.; Berhampur University, Odisha; F irst class

• 1998, 12th ; Khalikote College, Odisha ; Second class

• 1996, 10th ; MBD High School, Odisha; First class

ADD I T IONAL QUAL I F ICAT ION

• PGDBM in HRM; IGNOU, New Delhi; F irst class - 2012

• Diploma in GMP; Professional Management Academy, Pune, Maharashtra; F irst class

PROF I LE SUM MARY

• A competent professional with over 8 years of experience in Q uality Assurance and

B usiness Development.

• Demonstrated excellence in investigations for Customer Complaints, Deviations and Quality

E vents, CAPA management, Audit support during various Health Authority inspections and

response to observations from such inspections.

• Excel in handling of change controls, preparation of SOPs and t raining and quality system

i mplantation.

• Handled Process validation, cleaning validation, Mock Recall, In-process Quality Assurance,

Release of RM, PM and FDF for Oral Solids, Regulatory Communication and Compliance

• A logical thinker and observer possessing interpersonal skills, leadership and team

building skills.

CORE COMPETENC IES

Investigation of Customer Complaints:

• A key team member for investigation of customer complaints and review, approval and closure of

complaint investigations.

• Responsible for timely review and respond to the management and the customers.

• Use of Different Tools for handling and investigation of complaints

Deviation Handling:

• One of the team members for investigations of deviations, review, approval and closure of deviation

reports.

• Periodic t rending of deviations and developing awareness for reduction of deviations.

CAPA Management:

• Approval and t racking of the CAPA derived for various systems like deviations and investigations,

health authority inspections and self inspections.

• Ensure and evaluate the effectiveness of CAPA.

A udit Support for Health Authority inspections and response to observations received during

i nspections:

• Ensure t imely availabili ty of the documents requested the external inspectors and review the

documents prior to submission to inspector.

• Prepare appropriate responses to the observations cited by the health authority inspectors,

communicate internally and monitor the progress of response sent.

• Support to auditors with proper and justifiable explanation to represent the organisation.

• Assist in preparation of audit plan, t racking and review of all audits conducted at site by internal

and external auditors.

Validation Team:

• Assist in preparation, implementation of process validation and cleaning validation.

• Ensure appropriate and effective implementation of validation report

• Evaluation and review of the process validation reports and validation planned against the

validation master plan.

ORGAN ISAT IONAL EXPER IENCE

Apr. ‘10 – till date; Sandoz I ndia Pvt. Ltd., Navi-Mumbai as Executive

H ighlights:

• Responsible for handling of customer complaints (external and internal)

• Preparation of complaint investigation report through different investigation tools like Fishbone,

P rocess Mapping, Onion Peeling, 5 Why’s, Brainstorming etc.

• Reporting to Higher Authority, Escalation to Management of Critical Incidents, Complaints and

Deviations

• Involve with t racking, investigation, closure, identification of CAPA system

• Responsible for Regulatory support, Goods return and Global Reporting

• Evaluation of Change Controls for the impact assessment of the proposed changes and compilation

of the changes proposed considering the features like scientific and technical requirements, CGMP,

cost, capacity and feasibili ty of operations

• Responsible for the periodic review of the customer complaints, deviations and change controls

• Derivation of CAPAs with the objective of the improvement of the system towards the Regulatory

and Quality Compliances.

• Responsible for the t imely implementation of the changes or CAPAs in all departments of the plant

and closure of the same.

• Tasks of resolving the technical and Regulatory issues and provides the solutions in a timely way.

• Conduct effective t raining for my systems to t ime to t ime support to HR dept.

• A Certified Investigator for change management, market complaints, Deviations etc. for Novartis

L td.

• Responsible for Risk Management.

• Identification of Risk involved and Analysis of Risk through different Tools like FMEA etc.

• Preparation and implementation of various SOPs within timeline

• Stellar role in:

o Reviewing and provision of various documents as requested by various Heath Authority

I nspectors visiting the site

o Independently representing to the various Heath Authority Inspectors the systems

M ar. ’08 – Mar. ’10 with Unique Pharm. Limited, Bharuch, Gujarat as Officer

H ighlights:

• Responsible for preparation for various Audits and document support to the line Manager during

various audits.

• Responsible for review of Annual Product report and Product Quality Reports pertaining to the

I nternational guidelines

• Responsible for timely provision of the data to the regulatory department from site required for

various registrations and variations

• Responsible for Regulatory compliances and regulatory communication

• Responsible for Market complaint Investigations

• Responsible for Deviation investigations

• Responsible for handling of Change controls

• Responsible for handling of Mock recalls

• Responsible for preparation and implementation of various SOPs

• Responsible for preparation and execution of the Cleaning validation activities

• Responsible for Preparation and execution of Process validation Protocols

• Responsible for review of the APRs and PQRs

D ec. ’05 – Mar. ’08 with Mepro Pharm. Pvt. Ltd., Surendranagar, Gujarat as Officer

H ighlights:

• In charge of all the IPQA activities.

• Responsible for support for Market complaint Investigations

• Responsible for Deviation investigations

• Responsible for preparation and implementation of various in-process SOPs

• Responsible for appropriate execution of Process Validation Protocols

• Responsible for the release of RM, PM, SFG and Finished goods

• Responsibili ty of implementation of cGMP at shop f loor for manufacturing of oral solids

P ROJECTS UNDERTAKEN

Organisation : Sandoz Pvt. L td.

Period : Dec’ 10 to Jun’ 11

Title : Reduction of lead t ime of investigation of Complaints and Deviations and Closure

of

i nvestigation of Customer Complaints and In ternal Deviations within t imeline

and No Overdue

Organisation : Unique Pharma. L td.

Period : Jan’ 2009 to Dec’ 2009

Title : Implementation of Training System in Plant applicable to all levels of associates

COMPUTER SKILLS

• Well versed with MS Office, MS Outlook and In ternet

• Well versed with computer systems like SCADA, AWC, Track Wise

PERSONAL DETA I LS

Date of Bir th : 19th J uly 1981

Father’s Name : Sri K. Ganapati Patra

Religion : H indu

Nationality : I ndian

Mari tal Status : M ar r ied

Hobbies : Reading Books, Listening Music

Skills : Thorough, Meticulous, Analytical, Investigative, Research & Review,

A nticipating

Current Address : # 6, B Wing, Shri Sai Mangal CHS, Balaji Nagar, Thakurli, Dombivli (E),

T hane,

M aharashtra, India –421201

Permanent Address : At: Narayani Nagar, P.O.: Kodala, Dist.: Ganjam-761032, Odisha

L anguages Known : English, Hindi, Odiya, Telugu, Guajarati and Marathi

DECLARAT ION

I hereby declare that the above information given is t rue and correct to the best of my knowledge &

belief.

P lace:

Date: Sanket Kumar

Patra

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