1. Page 1 of 4
CV
POST APPLIED FOR : Manager Quality Control
NAME : SONEJI KRUSHNAKANT MAHESHKUMAR
ADDRESS : D – 408, Galaxy 88, Village: Hanspura,
Naroda Dehgam Road, Naroda,
Ahmedabad – 380008, GUJARAT (INDIA)
BIRTH DATE : 19th
August, 1979
MARITAL STATUS : Married
CONTACT No. : 09426040801; 099241370 63
CAST : Bhramshtriya
E-MAIL ADDRESS : sonejikrushnakant@gmail.com
EDUCATIONAL QUALIFICATION:-
 I have also passed B.Sc. Examination with Chemistry Obtained 49% of marks in April-2003.
EXPERICENCE: -
 Current job at M/s. Halcyon Labs Pvt. Ltd. As a senior executive QC, effected on january 2016.
 Kantam Pharmachem, Chhatral, Dist. Gandhinagar. API bulk drug manufacturer of
Glucocorticoid & Hormones.
 Responsibility: To independent handled QA/QC Laboratory, also good Practice in Product &
Development Laboratory.
APPROVED TECHNIICAL PERSON IN PHYSICO CHEMICAL ANALYTICAL TESTING
BY STATE GOVERNMENT, FOOD & DRUG DEPARTMENT)
M/s. Nexus Pharmachem Pvt. Ltd., Ahmedabad. (ISO 9001:2008 certify co.) API bulk drug manufacturer
of Glucocorticoid and its salts. As a QA/QC In charge on continued from April, 2008 to December – 2014.
 M/S. Kairav Chemical Limited, Santej. WHO cGMP certify API bulk drug manufacturer of
Diclofenac Sodium & Diclofenac Salts. As a Senior QA/QC Chemist, Between January 2006 to April
2008.
 M/s. Marck parenteral (I) Ltd, Village – Hariyala, Dist. Kheda, Gujarat.
As a Senior QC Chemist, Between 3rd
September 2005 to 13th
January 2006.
(Large volume Parenteral & sterile water for injection preparation)
 M/s. Swiss Parenteral Pvt. Ltd., Bavla, Dist. Ahmedabad – 382220.
Between 29th
September 2003 to 31st
August 2005. (WHO cGMP certify Co.)
Manufacturer of small volume parenteral dry powder & liquid injections.

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Function /
Activities
Profile Description
Planning
& control
Ensure completion of analysis within time limit and as per regulatory guidelines & in house
SOPs.
Properly schedule the analysis & ensure accuracy & precision should be maintained by
chemists while testing.
Set priorities for department staff & inline the activities as per the need of the organization.
Implement SOP to bring process efficiency & to save analysis time.
Quality
Management
Maintain c-GMP, EU-GMP, WHO & ISO standards for incoming materials, ensuring
stringent adherence to quality standards.
Participate in OOS investigation.
Approve and reject the raw material, finish product & intermediate product and packaging
material.
Approve all the standard test procedures and specifications related to quality control.
GAP Analysis: Periodically perform a process audit to identify the gap between set standards
& actual working. Prepare report of this analysis & ensure the gap to be filled within a
stipulated time period.
Identify the quality needs in relation to overall strategic plans.
Avoid any kind of deviation in the SOP & adhere to the quality policy of company.
Analysis &
Calibration
Ensure accurate & timely analysis of API/formulation, raw material, packing material,
finished product & in process product.
Monitor proper allocation of samples to chemist.
Track the average analysis time of samples & set standards in order to keep in control the
total time required for analysis.
Ensure that all instruments are calibrated periodically & review documents of calibration
Ensure proper maintenance of & update of records of analysis as per drug rules.
Ensure proper qualification & calibration of the new & existing instruments/ equipments in
QC dept.
Working
Standards,
Reference
standard &
control
samples
management
Ensure proper preparation & maintenance of working standards & reference standards.
Ensure proper monitoring & observation of control samples periodically and to report to the
in-charge.

3. Page 3 of 4
Function /
Activities
Profile Description
SOP
preparation
&
compliance
Ensure preparation of SOP relating to quality control as per current guidelines & its 100%
compliances.
Perform critical analysis of existing SOP & suggest changes (if any) required in present
system.
Documents
review
Review raw material and finished product planning as per production schedule.
Review the RM/PM/FG report.
Review of Raw material, finished product & stability samples.
Review of technical documents received from Validation cell in QC.
Responsible for review of all quality related documents such as SOP, specification, method
of analysis.
Responsible for maintaining all QC documentation records to comply the regulatory
requirements.
Cost
Reduction
Identify at least two cost reduction technique to control the total cost of analysis without any
production. delay.
Periodically educate the chemist on ways & means of cost effective analysis.
Ensure proper utilization of chemicals, glassware, machineries & all other facilities of QC
department.
Safety &
Hygiene
Ensure a safe work environment for all chemists in QC and ensure that they are working as
per safety guidelines of the company.
Ensure good work condition is maintained in QC to all chemist should follow all GMP norms
related to personnel hygiene, while working.
Team
Building
Set goals for next 2 years for QC team, goals should be specific, measurable, and realistic
and time bound. It should also include benchmark and target date of completion.
Prepare Action plan for the development of subordinates, management for non-performers
and top performers of the department.
Participate in recruitment & selection of staff for QC & all other technical persons in the
company.
Participate in performance reviews of technical staff.
Provide timely inputs for identifying training needs of QC staff.
Other
important
work
Participate in successfully completing Internal Audits & implementation of corrective &
preventive action plan.
Give suggestion in vendor selection.
Report
Check and analyze daily reports of chemist/subordinates.
Ensure the monthly report of department should be submitted before 7th of every month to
General Manager QA.

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Function /
Activities
Profile Description
Content of Monthly report :-
• Total no. of analysis planned & done in a month
Reworking.
• OOS investigation (if any) carried out & its results.
• Occupancy data of machine & chemist.
• Chemical consumption data (comparative analysis with last month).
• Breakage of glassware (if any & comparative analysis with last month).
• Trainings given to chemist in the month.
• Deviations done (if any) along with cause & justification.
Corrective & preventive action plan for development of department.
Coordination with: Interdepartmental coordination for ensuring smooth functioning of the
department on following points:
• Quality related issues, deviations (if any) & to solve all routine problems related with
department. – Dy. Manager Quality.
• Product priority & planning – Manager Production.
• Problems related with Sampling of RM – Warehouse In charge.
• Development of department (excluding routine issues).
Personal
Profile
Strong in people management.
Should have exposure of domestic & regulatory API / formulation manufacturing
companies.
Should have minimum 2 years of exposure at managerial capacity.
Average stability in last companies should be not less than 7 years.
Present
salary
Rs.3,65,000/- p.a. (Gross) INR
Expected
salary
Negotiable
Yours Faithfully,
(K. M. SONEJI)