Manu12061978

Full CV / Resume

I am a Post-Graduate degree holder in Microbiology and having 15 plus years of post-qualification experience in QA (Quality Assurance) pertaining to Sterile Dosage Forms. I draw experience from reputed Biotech, Biopharma and Pharma companies. Also, I have completed MBA (Correspondence Course) in Total Quality Management (TQM).

I have applied knowledge of CQV and have adequate experience of design and development of QA infrastructure right from the project stage. Having served in APIs and Formulations of Biotech, Biopharma and Pharma, I have confidence in taking middle-management role in companies who are in consulting or manufacture and market entire range of pharmaceuticals/Biopharmaceuticals.

I have served in companies who meet international quality standards like US FDA, EMEA, TGA, and WHO- Pre-qualifications.

As Asst. Manager, Validation I have contributed effectively in CQV (Commissioning, Qualification and Validation). Also, I have contributed in design, development and maintenance of sound Quality Systems. I could successfully ensure compliance in all areas of responsibility I was entrusted with to meet regulated market standards and sustain marketability of products in those countries.

I have strong belief in ethics, values and transparency and they have been the driving factor throughout my career.

My potential and leadership qualities were well recognized by my peers and supervisors. I have received recognition for outstanding contribution during my tenure at various positions.

I have command in communication skills in English and other Indian languages. I also possess good training and presentation skills.

Recently, I scored 7 out of 9 bands in IELTS conducted by British Council.