1. CURRICULAM VITAE
K.RAJANI KANTH,
H.NO. 3-7-92, INDIRANAGAR,
RAMANTHAPUR,
HYDERABAD-500 013.
Mobile No. : 9959070490
Career objective:
I foresee myself as an effective contributor for an organization that has to face
international competition in its endeavor to succeed. I believe my constancy of purpose,
Initiative and inner drive will enable me to play an effective role, thereby achieve results
and thus grow with organization.
Professional Strengths:
 Quality systems  Planning &
execution
 Handling market complaints
 Regulatory Compliance  Audits  FDA Licensing
Educational qualifications:
Academic:
 M.Sc. from Kakatiya University
 B.Sc. (BZC) from Osmania University
 Intermediate under Board of intermediate
 S.S.C. under Board of secondary Education
Soft ware Exposure:
Higher diploma in software engineering from APTECH in October 1998-99
¨ Operating systems : MS-DOS,WINDOWS-98/2000/NT Cont...
Professional experience:
Experience in M/s Immacule Lifesciences Pvt. LTD :
Working as AGM QA in Immacule Life Sciences Pvt. Ltd. as from April 2016 to till date
at Nalagarh,Himachal Pradesh . Handling a team of 25 nos.with 4 team leaders looking

2. after QMS,Validations,document review and IPQA.
Immacule Life Sciences is the lyophilized injection facility exclusively designed for
Regulatory Market on green building concept. It is the joint venture of SRS Pharma and
JCBL group. It is presently working for ANVISA and MHRA certification.
ORGANIZATIONAL EXPERIENCE & PROFICIENCY FORTE
Key Responsibilities:
 To ensure manufacture of good quality products as per the agreed Quality norms
along with Production plan at the most optimum cost, and in 100% compliance
with CGMP requirements.
 To support new product development and its launches with quality product
reviews.
 To coordinate with R&D and QA for Technology transfer of products.
 To ensure most qualitative vendors for products by identifying vendors and
manufacturers for RM/PM which are cost effective.
 Vendor development and management in line with CGMP requirements and
guidelines budgeting and control.
 Cross functional support (QA for compliance, Marketing and Sales for New
initiatives, R&D for product development etc).
 To ensure 100% compliance of CGMP requirements at TPM facilities with
regards to Quality.
 Conduct GMP and Quality system audits at own sites/entities (e.g. production
sites and development entities) and Third party contractors or suppliers as lead
or supportive auditor to monitor that all aspects of the operational business
comply with GMP legal and regulatory requirements and the Quality Manual and
Policies.
 Review and evaluation of protocols, data & reports to ensure the clarity,

3. consistency, & conformance to regulations, guidelines& regulatory strategy as
well as suitability for submission to regulatory agencies
 To implement the potential opportunities to enhance risk based regulatory
approaches.
 Evaluation of Product complexity as per QRM review and improvement in
Product Quality and Manufacturing.
 Provides technical evaluations for change requests, quality investigations
(including deviations and complaints), and product quality reviews
 Provide leadership and direction to the technical support team in accordance with
overall business unit strategy.
 Provide regulatory guidance to departments or development project teams
regarding design, development, evaluation, or marketing of products.
 Liaison with QA to ensure compliance with cGMP and regulatory
expectations/licensing requirements for change/transfer
 Develop regulatory strategies and implementation plans for the preparation and
submission of new products.
 Provides technical assessment for proposed validation studies received from
third party manufacturers
 Manage regulatory agency inspections and/or product recalls.
 Responsible for providing support on R & D and technical marketing.
 Responsible for new products/formulations protocols and permissions as per
DCGI and CDSCO rules
 Implement or monitor complaint processing systems to ensure effective and
timely resolution of all complaint investigations.
 Monitor emerging trends regarding industry regulations to determine potential
impacts on organizational processes.
 W.H.O GMP, c GMP, Schedule M audits of the Contract Manufacturing

4. Organizations focusing on manufacturing infrastructure, quality assurance/quality
control, purchasing processes, human resource, corrective and preventive
actions, quality management system, etc_ to assess their overall capabilities to
take up the production of products of desired quality
 Monitor that Corrective and Preventive Actions which are necessary due the
audit findings are implemented appropriately and as per schedule.
 Evaluation and trending of audit and inspection findings
 Maintenance of audit data in a related data system (incl. reports and follow-up of
audits).
 Support of training sessions, audit planning and risk assessments (e.g. for
supplier qualification).
 To coordinate audit and to provide response of the regulatory authorities and
customers.
 Review of technical agreements, Annual product reviews and trending process
related data.
 Review of process optimization report of executed validation batches through
technology transfer.
 Review of Product Quality Review, Stability data and control sample review and
archival of respective documentation.
Experience in M/s Sanzyme Pvt. LTD :
Worked from July 1999 to 2015. In M/s Sanzyme LTD (Earlier known as UNI-SANKYO
LTD), a first Indo-Japanese joint venture established in 1969, enduring strength of
SANKYO Company Ltd, Japan.
Joined as technical assistant on July 1999 in production department(Hormone
Injectable plant) .
Production Experience:
From July 1999 – March 2006 Worked as a technical assistant in the production
department, performing the activities like:

5.  Implementation of Standard operating procedures (SOP’s) in shoop-floor
 Participation in Production activities and Documentation
Quality Assurance:
In March 2006 I was deputed in quality assurance department and promoted as
Quality Assurance Executive. In April 2007 I have been promoted as Sr.Executive
QA and in April 2010 Promoted as Asst. Manager QA based on my performance. In
March 2012 Elevated as Manager QA. Total experience gained in QA department in
9 years. In March 2014 Elevated as Head Quality compliance looking after QA and
QC quality compliance.
Reporting to CEO of the company.
Cont...
Skills :
Ability to work well under pressure, strong interpersonal skills, communication skill,
presentation skill, relationship building, work in a team environment, flexibility and
willingness to adapt in a changing environment. Demonstrate leadership, sound
decision making, and problem solving skills. Ability of team building, self motivated.
Achievements:-
 Development of technical staff by trainings & motivation to face different
regulatory, LL parties & other customer audits.
 Best trainer & best auditor appreciation from higher Management.
 As a team leader achieved WHO GMP certification and new business
development from the LL and P to P by successfully complying audit
requirements.
Specific Tasks:
 Involved as one of the key person in the New Facility at Shameerpet [Project]
from initial Design qualification to execution, documentation till manufacturing of
the product and Approval from the regulatory body’s.Plant is now with EU GMP
certification.

6.  As a validation team member involved in the development and review of
DQ,IQ,OQ and PQ documentation of the area & equipments.
 Review and checking Audit Compliance of our own third party locations
[Tablets,capsules,Sachets etc.]
Audits faced:
Domestic Audits:
 WHO GMP , SUN Pharma,Ferring Pharmaceuticals Pvt. Ltd.,
Zydus cadilla,Emcure,Mylan,Abbott,Lupin,Glenmark,Cipla,Intas
Indian Immunological's Ltd,Svizera healthcare&Provime
Export Audits :
 MHRA
 ANVISA
 ANVIMA
 UKRAINE
 Poland (EU GMP Certification)
 Kenya
 Sudan
 Srilanka
Cont...
Principle Responsibilities handled in QA:
 Monitoring of Effective implementation of Good manufacturing practice & QMS
 To face internal as well as External GMP audits and monitor compliance.
 Sanzyme third party locations audits,Self-inspection and quality audits and
followup of audit compliance.
 Review of the documents, management systems and any suggestions for
continues improvement of the system. Ensuring the effective implementation of
the same.
 Plan for Internal self-inspections of all departments as per Self Inspection
Schedules
 Final review of Batch documents for its completion prior to release of product.
 Monitor and control activities at production Deviations / NCR / Change controls.

7.  HVAC,Process validation,cleaning validation & stability protocol review &
implementation.
 Planing and Implementation of Qualifications and validations in coordination with
validation team.
Cont...
PERSONAL INFORMATION
Father’s Name: K.Ramesh Babu
Date of Birth: 27-06-1977
Nationality: Indian
Marital Status: Married
Languages Known: Telugu, English & Hindi
Place: Hyderabad
Date: (K.RAJANI KANTH)
Present CTC: 18 Lacs/Annum
Expected Salary: 25 Lacs/ Annum
Notice period: 3 Months