RESUMESANJEEV RANJAN

A-224 ,IInd Phase,Janapriya ArcadiaDarga Road, Kowkoor, Secunderabad

Contact: 09618255197 (m)Email: snjv_ranjan@yahoo.com

SUMMARY:A professional with fourteen years of experience in different areas of Pharma Industry. Primarily worked for the Production department but also has the working experience in Quality Assurance.

JOB PROFILE

Company : Sigachi Industries Pvt. Limited – HyderabadDuration : From – Nov 2015 To – till dateDesignation : QA Manager

Work Profile To be responsible for all activities in the Quality Assurance, including cGMP/cGLP,

documentation and implementation of departmental quality systems. Responsible for in Process document control and records retention as per cGMP. Review of executed Batch Production & Control Records and Process documents. Preparation of Standard Operating Procedures (SOP’s), and (BPCR). Monitoring dispatch related activities and solely responsible for timely release of Batch. Responsible for IPQA Checks during Production. Routine inspection of various departments to maintain cGMP (current Good Manufacturing

Practices) compliance at all levels. Responsible to investigate the root cause for the complaints received and their timely closure by

taking appropriate corrective & preventing actions required. Conducting regular Internal Audit for Production in order to ensure that all the set guidelines are

being followed. Review and compile the Deviations and change controls. Facing customer and regulatory audits and audit follow-ups. Preparation of Annual Product Quality Review and Process Validations.

Reported To : Executive Vice ChairmanAudits faced : ISO 9001: 2015 & FSSC 22000, Customer Audit

Company : Alkem laboratories Limited – DamanDuration : From – July 2008 To – Oct 2015Designation : Sr. Executive

Work Profile Coordination & Planning with QA Dept. for regular production plan and validation activities. Monthly, Weekly & daily planning production schedule so as to achieve the given production

target within stipulated time. Co-ordinated closely all activitieseg. Production planning, Raising of production notes& follow

ups through necessary organizational and technical interface.

Direct supervision of all the stages of manufacturing & packing activities.Dry syrup, Capsule, Tablet department.

Tracing & Tracking of all documents, eg. Change Control, Deviations etc. Conducting Self Inspection Audits and Imparting on job training related to CGMP/regulatory

requirements. Preparation & reviewing of SOP’s Handling of CVC bulk packing line 220 BPM and 120 BPM. For U.S Market.

Reported To : Dy. GM -ProductionAudits faced :USFDA,MHRA,TGA.MCC

Company : Intas Pharmaceutical Ltd. AhemadabadDuration : From – Sept 2006 To – June 2008Designation : Sr. Executive

Work Profile Monitoring of routine Production activities. To carry out validation activities such as preparation of protocols & reports. Review & Ensure the completeness of all production records. Conduct the investigations as per the complaints. Participating in investigations pertaining to deviations OOS &Failure investigation. Conducting Self Inspection Audits and Imparting on job training related to CGMP/ regulatory

requirements.

Reported To : Manager-ProductionAudits faced :MHRA, USFDA

Company : Strides Arcolab Ltd. BangaloreDuration : From – Dec 2004 To – Aug 2006Designation : Executive

Work Profile Preparation of IQ/OQ/PQ protocols. Preparation & review of SOP’s,BMR’s and MFR’s. Conduct the investigations as per the complaints. Participating investigations pertaining to deviations, OOS & return goods. Participate in designing Training. Ensure the completeness of all production records. Conductance of Internal Audits as delegated / assigned.

Reported To : Team Leader -ProductionAudits faced :MCC, WHO

Company : Torrent Pharmaceutical Ltd. AhmadabadDuration : From – Aug 2004 To – Nov 2004Designation : Sr. Technical Officer

Work Profile Production planning and manpower handling. Co ordination with raw material and packing material stores in order to

Preparation, reviewing, of production related documents like SOP, BMR and BPR. Super vision of manufacturing processes like Granulation, blending, Compression in accordance with GMP requirements. On job training to workman to comply GMP requirements on shop floor.Assisting with QA

department in order to plan and implement process Validation, cleaning validation activity on shop floor.

Reported To : Sr. Executive -ProductionAudits faced : WHO

Company : Alkem Laboratories Ltd. DamanDuration : From – July 2000 To – July 2004Designation : Production Officer

Work Profile Production planning and manpower handling. Co ordination with raw material and packing material stores in order to Streamlining day to day production activities. Super vision of manufacturing processes like Granulation, blending, Compression in accordance with GMP requirements. On job training to workman to comply GMP requirements on shop floor. Assisting with QA department in order to plan and implement process Effective resources planning and utilization of men, material and machine, thereby cost reducing

and quality consciousness approaches in team.

Reported To : Manager -ProductionAudits faced : WHO, MHRA, MCC South Africa

ACADEMIC DETAILS Bachelor in Pharmacy (Karnataka University, Dharwad) MBA with the specialization in Operational Management (Sikkim Manipal University) Diploma in pharmaceutical Production Management in the year July 2001from I.P.E.R.-Pune Diploma in the Pharmaceutical Packaging Management year July 2002 from I.P.E.R.- Pune

SEMINARS ATTENDED Documentation in Pharmaceutical Industry ISO-Awareness programme

SKILLS IN COMPUTER Operating System - DOS,MS-Office ERP system - End user knowledge of SAP in production

SANJEEV RANJANDate : Place :