Hiren Shashikant Shah

E-mail : shahhs31@rediffmail.com Mobile: +919879401314,+917898153510

hirenshah9465@gmail.com

OBJECTIVE

To take any challenging position where my knowledge in Quality can be utilized for the maximum benefit of
the organization. Open to new ideas and an attitude as well as potential to grasp & implement new
technologies.

EXPERIENCE

Presently I am working with Symbiotec pharmalab ltd. As Assistant Manager QC .I have more than 22 years
Experience in Quality field.

Company Profile:

• Symbiotec is one of the India’s largest manufacturer of Steroids.

• We are at Indore manufacturing various Steroid[API].
• Our facility is approved by US FDA,EUGMP,WHO & ISO9002

QUALIFICATION

BSc. (Chemistry) from South Gujarat University, Surat (Gujarat)

TECHNICAL SKILLS

• Maintenance and up keepment of sophisticated analytical instruments.

• FDA approved for “chemicals & physico chemical testing” by FDA. Gujarat.
• Working knowledge of computer & internet.
• Coordinating with marketing department as well as production department to fulfill market requirements.
• Handling dispatches of finished product for exports and local markets.
• Responsible for the entire QC related activities
• I am well verse with operation and Calibration of Sophisticated analytical instrument like.

 HPLC Tsp. Agilent, Water.

 UV Visible Spectrophotometer Shimadzu, Perkin Elmer.
 GC Perkin Elmer, Netel.
 FTIR Perkin Elmer, Shimadzu.
 Autotitrator Mettler
 Polari meter Auto Poll, Rajdhani.
 Digital Balance Shimadzu, Mettlor.
 K / F Apparatus Mettlor, Veego.
Q.A. ACTIVITY

• Review SOPs, specification and revised update as per the requirements of cGMP.
• Review and updated existing SOPs / Specification / MOA by incorporating all the statutory / regulatory
requirements as and when required.
• Implements of deviation reporting and change control systems.
• Equipments, analytical instrument qualification.
• Stability studies and reporting.
• Handling of market compliant.
• Review of BPRs and analytical records.

QUALITY CONTROL ACTIVITY

• Analytical and certification of Raw materials, Intermediates, Finished product (API, formulation ) and
packing materials.
• Preparation method of analysis, specification and SOPs for analytical instrument.
• Calibration and operation of analytical instrument like HPLC, IR, UV-VIS spectrophotometer, GC etc.
• Standardization of volumetric solutions.
• Preparation of stability protocols and performed stability studies for intermediates, API.
• Conduction of OOS investigation and documenting.
• Responsible for the entire QC related activities.
• Analytical method validation of non compendia Pharmaceuticals products. Process validation and
cleaning validation.
• To give analytical support to P.D.Lab for improvement in quality & cost of finished products and
intermediates.
• To give analytical support to R&D for trials & scale up batches
REGULATORY AFFAIRS ACTIVITY

• Co-ordination with FDA authorities.

• Preparation of various protocols.

EXTERNAL TRAINING

• Internal auditor as per ISO9002

• Quality assurance concepts.
• Who GMP aspect.
• Personnel Effectiveness.
EMPLOYMENT HISTORY

• Stepping Stones Current

• Started my carrier with Mittolia Chemical P. Ltd, Ankleshwar as QC Chemist in April 1987 and at
present I am working with Symiotec pharmalab Ltd. Indore as Assistant Manager QC.

Name of Company Period Mfg, Details

Symiotec pharmalab Ltd August – 2010 to Tile date Mfg of various steroids
Alkem Laboratories Ltd. Oct – 1999 to 28 July - Bulk Drugs & Intermediates
Ankleshwar 2010 Satranidazole,CamylofineDiHCL,
Sucralose, Iron Suppliments, Risedronate
Sodium.
PCI Fine chem P.Ltd. Ankleshwar Feb - 1993 to Oct – 1999 Bulk Drugs & Intermediates Ampicillin
Trihydrate, Amoxycillin Trihydrate,
Cloxacillin sodium, Pyrazinimide.
K.C. Laboratories, Ankleshwar. April – 1990 to Jan – 1993 PharmaFormulation.Liquid & tablat.
Mentor Chemicals & Dec – 1989 to Mar - 1990 Bulk Drugs & Intermediates
Pharmaceuticals P. Ltd. DmaecHCL, Phenarmine mealate,
Ankleshwar. Mefenamic acid, Ferrous Glycine
Sulphate.
Mittolia Chemicals, Ankleshwar July – 1987 to June – 1988 Lab Chemical.
Empire Medicine Ltd, Ankleshwar July – 1988 to Nov –1989 Pharma Formulation Liquid & capsule.

PERSONAL DETAILS

Address : A-11, Pushpam Bunglow,

Behind Rachana Society,
Maktampur Police Chouki, Bharuch,
Ph : (02642) 226436.

Date of Birth : 09th Apr – 1965

Marital Status : Married

Language Known : Gujarati, Hindi, English.

Pasport No. : 0788122. Validity: 13/02/2017

Salary Drawn : 6.0 Lacs / Annum. CTC

( HIREN SHAH )