Curriculum Vitae

SAMIR PATEL

Qualification : Bachelor of Pharmacy (B.Pharm)

Master of Pharmacy (M.Pharm)

(Pharma. Technology - awaiting for results)

Nationality : Indian

: 05th Feb. 1978

Date of Birth

Gender : Male

Current Designation : Sr.Manager - Q.A. (Zydus Cadila)

: Sector : 7-‘D’, Plot No. : 1246/1

Address

Gandhinagar. Gujarat – 382007

Contact No. : M : +91-992*******

E-Mail : acec5a@r.postjobfree.com

JOB OBJECTIVE

Seeking senior managerial assignments in Quality Assurance with an organization of reputed

Pharmaceutical / Healthcare Industries.

CARRIER OBJECTIVE

Secure a challenging position wherein my attributes, experience and communication skills can

be utilized in obtaining personal career goals and those of organization.

PROFILE SUMMARY

Over 14 Years experience in Quality Management System, Regulatory Audit Compliance

Inprocess quality assurance and Validation System which includes managerial experience.

Excellent leader with conceptualizing measure to optimize the budget / resources / capacity

utilization. Facilitates problem resolution, resource utilization, coaching and mentoring of

team members. Active member of technical recruitment committees.

Strong communicator with the ability to ensure for the execution of time bound

deliverables.

Keep site in a state of inspection readiness for regulatory inspections and Group audits.

Continuous review on update and implementation of new requirements arise from

regulatory guidance documents in consultation with regulatory department.

Specifically acquainted to handle Field Alert, Product Recall and response to warning

letter.

Provide expert support to sites during regulatory inspection, development of responses to

inspection findings, significant investigations and guidance regarding corrective actions.

Handled regulatory inspections USFDA, MHRA, ANVISA, WHO & Customer Audits.

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Curriculum Vitae

SAMIR PATEL

CORE COMPETENCIES

Sound knowledge and experiences of Oral solid (Tablet / Hard and Soft gelatine capsule) with

exposure of Parenteral, Lyophilisation, Nasal, Transdermal and MDI dosage forms too.

Quality Management System

Actively developed software/system for tracking, implementation and post effectiveness

checks of CAPA elevated by deviations, Incident, Market Complaint, OOS, OOT, Failure

Investigation, internal audit or regulatory inspection.

Expertise in maintaining records related to the Quality Management System.

Assist in driving quality and compliance across the manufacturing site & organization to

ensure on-going compliance with regulations, Health Authorities expectations and

company polices and standards.

Gap analysis and identification of the QMS documents against the site SOPs.

Communication of the same to the concern department for the implementation.

Periodic review of QMS documents to upgrade at site.

Ensure the effective Quality Management System in place at site.

Prepare and update the vendor list as per the schedule and compile the vendor evaluation

data. Perform audits of shortlisted vendors as per schedule. Maintain master data SAP

related to vendor.

QMS Presentation on quality matrix and index to senior managements.

In-process Quality Assurance

Special hold on ‘Handling of Market Complaint’, ‘Out of Specification’ and ‘Product Failure’

comprehensive investigation to identify the root cause and appropriate CAPA execution.

To evaluate impact assessment on product due to Deviation, Incident, Temporary Change

Control, Change Control raised by concern department.

Review of APQR / APR / PQR and trend analysis. Summarize and evaluate data by using

statistically tools. Assist in preparing recommendations based on APQR evaluation.

Approval of Master Batch Records.

Product assessment and batches release for sale to regulatory market.

Regular training for awareness of cGMP across the manufacturing units and ensure cGMP

compliance.

Establishing adequate measurements to monitor areas performance and participating in

the control and auditing of manufacturing and packaging operations to assure conformance

of products.

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Curriculum Vitae

SAMIR PATEL

Regulatory Compliance

Regulatory agency query response related to filled product dossier.

Interpretation of audit observations and its compliance.

Participation in preparation of audit compliance response report and tracking for

implementation of commitments.

Ensures establishment, implementation and adherence to quality pharmaceutical

manufacturing standards.

Validation System

Executions and summarize the Process Validation activity of solid dosage.

Qualification and Re qualification of M/c, Equipment/ Utility with Engineering Department.

Area Qualification as per cGMP and regulatory requirement.

Execution of validation master plan. Good experience regarding Cleaning Validation

activity and execution of cleaning validation.

Lead identified work streams for risk assessments and risk mitigation plan implementation

across site.

ORGANIZATIONAL EXPERIENCE (Start from current Job)

1. Zydus Cadila Ltd. (Ahmedabad – Moraiya) Sr. Manager - QA Since August 2007

2. Strides Arcolab Ltd (Bangalore) Area Leader - QA Mar. 2005 to July 2007

3. Torrent Pharmaceuticals Ltd (Ahmedabad) Te. Supervisor - QA Nov. 2002 to Feb 2005

Officer – QA

4. Lincoln Pharmaceutical Ltd. (Ahmedabad) Nov. 1999 to Nov.2002

Zydus Cadila (Cadila Healthcare Ltd,) (Since August 2007 till date)

Department: Quality Assurance Designation : Sr. Manager - QA

Job Profile:

Assist in the implementation of Quality culture in the Development functions through

attention to quality and regulatory compliance via training and integration with groups -

Participates in the defining and assisting in the implementation of Quality objectives /

strategies and Quality Plans across line functions at the site.

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Assist in the identification of areas of potential Quality risks and compliance issues, assist

in the monitoring the overall status of quality and compliance within organization on an

on-going basis and escalates issues to Senior Management, as appropriate.

Assist in the development of adequate key quality and performance indicators are

defined and implemented, regularly reviewed with Quality management and adequate

action plans defined and implemented, as appropriate.

Ensuring that Quality Assurance area goals and objectives can be accomplished in a

timely manner; Providing a positive, highly professional environment that can promote

open communication, creativity and continuous improvement attitudes; Enforcing safety

rules and attitudes to promote a healthy environment

Selecting, training and evaluating the performance of personnel. Recommending

compensation changes in a timely manner. Planning and providing developmental

opportunities for personnel in both technical and management areas to increase

productivity and encourage job satisfaction.

Reviewing and approving Quality Assurance and production investigation reports as

required. Evaluating investigation reports and all related documentation for compliance

with GMP’s, SOP’s and pharmaceutical regulations

Accountable for implementation of CAPA and to ensure compliance status against

Product Recall, Critical complaint and Regulatory inspection observations.

To approve the Standard Operating procedure, APQR / PQR / APR, validation protocol

and stability testing protocol and reports, specification etc.

Handling of regulatory, customer, self audit and internal audit.

Design and Implementation of Quality Management Systems at site.

Ensure all decisions are made regarding QMS applicability and deployment, considering

the risk of activities carried out on product quality, safety or efficacy.

Identification of Subject Matter Experts and assigning them the responsibility of the gap

analysis for the specific GQPs.

Timely escalation of issues / risks related to QMS to appropriate forum.

Impact assessment of the new or revised QMS documents on site. Communication of the

same to the cross functional department.

Tracking to ensure all the SOPs at site are in compliance with QMS. Ensure proper

issuance, retrieval and supersede of SOPs.

Handling and impact evaluation of Change Control, Deviation and Incidence.

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Curriculum Vitae

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Comprehensive investigation carried out to identify root cause and appropriate execution

of CAPA for ‘Market Complaint’, ‘OOS’, ‘OOT’ and ‘Product Failure’

Approval of Master Batch Manufacturing Record, Batch Packing Record, Raw Material

Specification.

Ensure tracking and timely closing of all CAPA raised through quality documents. Post

effectiveness checks of CAPA.

Impart technical training to the production staff. Ensure appropriate training regarding

new or revised quality documents to cross functional department.

Review the APQR/APR/PQR report and trending of inprocess parameters as well as

analysis test results. Summarize and evaluate data by using statistically tools. Preparing

recommendations based on APQR evaluation.

QMS Presentation on quality matrix and index to senior managements.

Participation in preparation of audit compliance response report and ensuring

implementation of commitments.

Quality evaluation of Exhibit Batches taken for different regulatory markets.

Ensuring reviewer qualification of employees involved with review of quality

documents.

STRIDES ARCOLAB LTD. ( From March -2005 to July -2007 )

Department: Quality Assurance Designation : Executive ( Area Leader ) - QA

Job Profile:

Validation and Qualification : To Prepare, Execute and summarize the Process

Validation activity of solid dosage forms like Tablets, Hard and Soft Gelatine Capsules.

Qualification and Re-qualification of M/c, Equipment/ Utility with Engineering Department.

I.P.Q.A. : Monitoring Inprocess checks in different dosage form like Tablets, Hard and Soft

Gelatine etc.

Conducting audits of Manufacturing and Packaging Records and QA process related

documents to assure that documentation is free of errors and complies with GMP’s and

SOP’s.

Area Qualification: Qualification of area according to cGMP and regulatory requirement.

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SAMIR PATEL

SUSTAINING ACTIVITY

SOP : Preparation, Review, Training and Distribution.

Training : Prepare employee training curriculum, annual schedules and coordinate with

internal trainers and execute the training as per schedule. Maintain, check and update

the training records. Assess the training evaluation questionnaires and conclusion of re -

training requirements.

cGMP Compliance : Regulatory compliance across the company by developing a cGMP

system and execute of SOP across the plant.

QMS : Handling of Change Control, Deviation, Incidence, Market Complaint and OOS.

Issuance and control of Quality Documents. Updating of SMF and Quality Manual.

Cleaning Validation : Good exposures regarding preparing Cleaning Validation Protocol

and execution of cleaning validation activity

To update documents for sustaining and enhancing quality standards.

Engage to guide team on departmental issues; provide on-job training to team members.

TORRENT PHARMACEUTICAL LTD . ( From November-2002 to February -2005 )

Department: Quality Assurance Designation : Technical Supervisor - QA

Job Profile:

cGMP Compliance :- To Build a system regarding cGMP and look after to follow SOP

across the plant.

I.P.Q.A. :- Conducting In process quality checks and implementation and execution of

allocated QA related systems and processes in accordance with the relevant SOPs.

Lineclerance activities.

Batch Release:- Batch Release in interdepartmental as well as Finished Product after

verification of BMR, BPR and analysis results.

SAP :- Apparent knowledge regarding to QA function in SAP System

Exposures regarding Process Validation, Qualification, Cleaning Validation, SOP Preparation

and Review, Tanning, Area and M/c. Qualification, Market Complaint, Self Audit, Internal Audit,

Annual Product Review, Stability, Review and Control of Quality Docum ents like Temperature

and RH, Differential Pressure, M/c. Log card, Retain Samples. Issuance and Achieving of

BMR, BPR and other Quality Documents.

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Curriculum Vitae

SAMIR PATEL

LINCOLN PHARMACEUTICAL LTD. ( From November-1999 to November -2002 )

Department: Quality Assurance Designation : Officer - QA

Job Profile:

Preparation and issuance of BMR and BPR of Tablet, Capsule, Dry Syrup and powder,

Ointment. Prepare controlled documents and distribute, retrieve, archive and destruct

controlled documents.

Regulatory :- Assemble a product dossier for different countries according to country

specific requirement.

Documentation work related to Validation, Quality Documentation, SOPs, Training and

IPQA Activity.

REPORTING OUTLINE

My current reporting to Head Quality Assurance. I handle 20 team members.

REGULATORY INSPECTION AND OTHER AUDIT EXPERIENCE

USFDA, MHRA, ANVISA, TGA, WHO, Customer Audits and other semi regulatory markets

inspection experiences.

SOFTWARE PROFICIENCY

Expertise in SAP and LIMS ( Laboratory Information Management System ) functional

operation.

MS Office

RESEARCH PROJECT

Project work was carried out on “Formulation and Evaluation of Oral Dosage Form Using

‘MUPS’ Technology for Selected Proton Pump Inhibitor Drug”. Thesis was prepared and

submitted to university for final approval.

Communicated article entitled “A Review on “MUPS” Technology” for publication by the

International Journal of ‘Pharmaceutical Research Scholar’.

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