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Manager Quality assurance

Location:
Chandigarh, Chandigarh capital, India
Salary:
13 lakh
Posted:
February 14, 2021

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Resume:

RESUME

PERSONAL PROFILE

I am an energetic, ambitious person who has developed a mature and responsible approach to any task that I undertake, or situation that I am presented with. I am an articulate, confident person who relish challenges and working under pressure. My greatest strengths are my research, communication and writing skills. I am excellent in working with others as a team to achieve a certain objective on time and with excellence.

CAREER OBJECTIVE

To pursue a career in an esteemed organization and to nurture my acumen knowledge acquired over the years to develop effective skills to maximize organization productivity and my career growth.

INDUSTRIAL EXPERIENCE (14 years)

Current-

Coral Drugs, API manufacturing Plant as Manager – Quality Assurance, (service period - from May-2015 to till date).

Previous-

Naari Pharma, API manufacturing Plant (A sister concern of Jagsonpal Pharmaceuticals Limited) as Asst. Manager – Quality Assurance, (service period - from Apr-2013 to May-2015).

Naari Pharma, API manufacturing Plant (A sister concern of Jagsonpal Pharmaceuticals Limited) as Sr. Executive – Quality Assurance, (service period - from Jan-2010 to Mar-2013).

Worked with India Glycols Limited, API Manufacturing Plant, Dehradun as a Trainee Chemist -Quality Assurance from Jan-2008 to Jan-2010.

Worked with India Glycols Limited, Kashipur as a Trainee Chemist-Quality Control from March-2007 to Jan-2008.

ACADEMIC QUALIFICATION

Sr. No.

Qualification

Board/ University

Year of passing

Division

1

M. Sc. (Org. Chemistry)

M.J.P. Rohilkhand University

2005

1st

2

B. Sc. (ZBC)

Kumaun University, Nainital

2003

2nd

3

12th

UP Board

1999

2nd

4

10th

UP Board

1997

2nd

PROFESSIONAL QUALIFICATION

Advance Diploma in Software technology form Hiltron Calc in year 2000 with 1st division.

COMPUTER SKILLS

Knowledge of Computer Fundamentals, MS DOS 6.22, Windows, MS Office (MS word, MS Excel & MS power point), AutoCAD and knowledge of SAP.

JOB PROFILE (Current) In Coral Drugs (API manufacturing Plant)

Implementation of GMP, Quality policy & QMS in all areas under the scope of SOPs as per ICH standards.

Determining, negotiating and agreeing on in-house quality procedures, standards and specifications

Specifying quality requirements of raw materials with suppliers.

To ensure the data integrity in line with expectations of all national and international regulatory guidelines.

Responsible to measure, monitor and improve the customer satisfaction level and ensure timely CAPA for all customer complaints / feed backs.

Responsible to validate and upgrade the processes, test facilities, methods at various stages in manufacturing.

Plan and implement quality audit schedules and be the Lead Auditor for all internal and external agency Quality audits and assess the adequacy of CAPA.

Ensure timely completion of document audits, method audits, process audits, and facility audits and provide guidance to team members.

Prepare Quality Plans, QA Procedures and Inspection and Test Plans.

Initiate periodic review and update Quality manual, procedure manual and forms / formats to reflect changes accordingly.

To ensure that the appropriate validations like process, cleaning, equipment, utilities, analytical methods etc. are carried as per the VMP.

To ensure all records are filled and signed on line.

Responsible for IPQA Review, Audit Compliance, Analytical Quality assurance.

Review of Analytical method validation reports, Analytical development reports and also conduct supervisory review/ approval of these reports.

Review and Approval of SOPs and all Quality documents from all the departments.

Review, approval and closure of Change Controls.

Responsible for maintaining quality management system including Root cause analysis and CAPA for deviations, laboratory investigation, OOS, OOT, rejection, customer complaints etc.

To impart the cGMP trainings to plant personnel.

To ensure APIs & Intermediates Quality, product release and dispatch activities as per cGMP & customer requirements.

Review and approval of Stability study program.

Responsible to review and approve qualification/ calibration/ validation & preventive maintenance of QC or Plant Instrument/ equipment.

Conducting quality risk assessment using suitable qualitative and quantitative tools.

Conduct supplier audit, qualification, their periodic assessment and Quality Technical Agreements.

Review of Process Development, optimization / Technology transfer documents (TTD).

Review and approval of Periodic Product Quality Review & Trend analysis.

Conducting Mock Recall to evaluate the effectiveness of the procedure for Product recall.

Responsible for implementation of 21 CFR part 11, part 68, part 210 and 211.

Ensure review of Audit trail of instruments (HPLC, GC, IR, UV etc) & their data backup.

JOB PROFILE (Current) In Naari Pharma (API manufacturing Plant)

Preparation & Review of SOPs for all the departments.

Implementation of GMP practices in all areas under the scope of SOPs.

Carry out Internal Audits for Regulatory Compliances.

Active Role in customer & regulatory audits. Responsible for submitting the compliance report.

Review, approval and closure of Change Controls.

Responsible for maintaining quality management system including document control, investigation of deviations, laboratory incidents, OOS, customer complaints, CAPA.

To impart the cGMP trainings to plant personnel.

To ensure APIs & Intermediates Quality, release, review of analytical data, batch records and dispatch activities as per cGMP & customer requirements.

Responsible for submitting Annual updates and amendments as per regulatory requirements.

Conducting quality risk assessment using tools like FMEA etc.

Preparation & review of Site Master File.

Responsible for review of compendia & in-house Specifications & Method of Analysis.

Review of Process Development / Technology transfer documents (TTD).

Preparation & review of Periodic Product Quality Review.

Conducting Mock Recall to evaluate the effectiveness of the procedure for Product recall

JOB PROFILE (Previous) In India Glycols Limited ( Pharmaceutical division- Dehradun)

Preparation and distribution of SOP of Quality Assurance.

Complete Sampling of Semi Finished products and finished products.

Ensure line clearance before starting of fresh batches and Quality and releasing of finished goods batches.

Preparation, Issuance and Reviewing of BPR/ BMR Sheets.

Qualification of Air Handling Units.(HVAC System).

Preparation Process Validation Protocols and Process Validation Reports.

All type of Computer related trouble-shooting and specific work associated with Quality Assurance department.

Preparation of Site Master File

Handling of Supplier Qualification

JOB PROFILE (Previous) In India Glycols Limited (Kashipur)

QC wet & instrumental analysis; eg KF, pH, Titration, Conductivity, water analysis, instruments like FTIR, UV, GC, HPLC as per Standard test procedures.

Knowledge of Fire & Hydrant system

Knowledge of SAP System, LIMS, Minitab etc

SKILLS AND STRENGTH

Dedicated towards the quality & detailed-oriented work.

Co-operative and patient.

Trouble shooting and provide solution to the potential issues.

Hard working, sincere and ambitious.

CURRENT EMPLOYER

Coral Drugs, API manufacturing Plant is a regulatory approved, an integrated research based pharmaceutical company that manufactures a wide range of high quality, active drug ingredients including steroids, non-steroids for oral inhalations.

PAST EMPLOYER

Naari Pharma, API manufacturing Plant (A Sister concern of Jagsonpal Pharmaceuticals Limited) is a company focused on female health with an emphasis on hormones producing fermentation intermediates & API/ Hormones supported by in-house R&D in each domain.

India Glycols Ltd, API manufacturing Plant is in the business of manufacturing of natural API’s and their intermediates.

AUDIT FACED

Successfully led and completed regulatory authority audits like USFDA, EUGMP on periodic basis, WHO Geneva, WHO India and various other regulated customer audits.

CO CURRICULAR ACTIVITIES

oActive involvement in EHS activities such as fire mock drill, trainings etc.

oConducted safety programs like Quiz, poster & slogan competition in the company.

BIOGRAPHICAL DATA

Father : Shri. M. C. Saxena

Mother : Smt. Suman Saxena

Born : 30th March 1982

Sex : Male

Marital Status : Married

Languages Known : English, Hindi

Blood Group : B+ve

HOBBIES

Reading inspirational Articles,

Listening Music,

Interest in Computers,

Curious to learn new things

REFERENCES

Dr. Vinayak Tripathi – (Technical Director – Coral Drugs), Contact - 981*******

Mr. Ranvir Singh Senger – (Sr. Manager - HR & Admin - India Glycols) – 969*******

Mr. Manoj Shukla – (Sr. Manager Production – India Glycols) - 969*******

DECLARATION

I hereby confirm that the information provided by me is true to the best of my knowledge and belief.

Date :

Place : SONIPAT (Pradeep Kudeshia)



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