M U HAM MAD M URSALEEN K HAN R AC

( US)

** ***** **** **, ****** MA USA 02119 857-***-****

k ace3w5@r.postjobfree.com

Qualification Summary:

• Two years of hand on experience in Pharmaceutical Quality and Manufacturing enables me to comprehend

SOPs, cGMP, ISO regulations and implement them accordingly.

• Familiarity with drug development process and clinical research through my PHARM-D background.

• Good understanding of FDA policies for IND/NDA/510(k)/PMA/ISO13485/QSR and electronic submission

as Common Technical Document (CTD) through my MS in Drug, Medical devices and Biologic regulatory

affairs.

• Administrative experience in Pharmaceutical setting and have ability to propose solutions to problems

encountered in Pharmaceutical operation.

• Ability to interpret regulations, guidance document and guidelines.

Education:

• MS Drug, Device, Biologic Regulatory Affair Mar 2015

Northeastern University, Boston MA GPA 3.84

• RAC (US) Certified May 2014

• FDA eCTD web based training course July 2014

• Pharm-D Dec 2011

University Of Karachi, Pakistan GPA: 3.63

Experience:

Sanofi Karachi, Pakistan

Quality Production Officer J AN 2013 to

A UG 2013

o Oversaw cGMP compliance to ensure safe and effective sterile drug manufacturing.

o Carry out process verification for Claforan a third generation cephalosporin parenteral product.

o Update process verification report for Claforan and Aventriax Injectable product.

o Review batch production record to ensure batch production in compliance to standards.

o Document and report deviations during manufacturing operation of sterile products.

o Responsible to prepare files for technical complaint of sterile products.

o Manage documentation of change control activities and report any such change control activities.

o Review and update SOPs for Pharmaceutical operations particularly in sterile production area.

o Implement gowning procedures for class A and B sterile production area in Claforan plant.

o Perform calibration of equipment’s to ensure pharmaceutical operation in compliance to GMP.

Martin Dow Ltd. (Formerly Roche Pakistan)

Quality Manufacturing Officer AUG 2011 to DEC 2012

o Responsible to ensure cGMP compliance in Tablet and liquid Manufacturing for non-sterile drugs.

o Organized line clearance activities before new batch manufacturing of non-sterile products.

o Review and update SOPs for non-sterile Pharmaceutical Manufacturing of tablets and liquids.

o Perform In-process control activities to ensure manufacturing in accordance to BMR.

o Calibration and Validation of equipment and process for non-sterile manufacturing.

o Conduct change control activities for non-sterile product and take any corrective action required.

Skills:

• Computer: Proficient in Microsoft Word, Excel, has created production reports.

• Communication: Strong verbal and writing skills.

• Cordination: Ensure GMP compliance through coordination with manufacturing team.

• Team player: Experience working with Quality team in pharmaceutical settings.

• Active listner: Ability to focus and understand instruction.

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