Ajay Pazhayattil

This is a critical decision making technical leadership role responsible for business operations across Canada, US, Netherlands, Mexico and India.

Some Key Highlights:
•Received Apotex award for the key role in 2013 Health Canada audit and FDA WL follow-up audit resulting in lifting of import ban for GTA sites.
•180-day patent exclusivity: Achieved 100% adherence to generic launches; with aggressive avg. 1/month rate.
•Introduced Product Development Statistical Group and novel industry benchmark PV statistical analysis.
•Developed and implemented electronic Technical Risk Assessment tool.
•Developed and implemented a complete validation solution based on Lifecycle, QbD approach (Validator).
•Nominated as business lead for global corporate projects.
•Drafted, implemented Validation Master Plan. (2011 FDA PV Guide based)

(Apotex Inc. employs 5, 000 and produces more than 300 generic pharmaceuticals in approximately 4, 000 dosages and formats. Apotex is one of the top generic manufacturers in the world. Technical Operations is part of Global PD-R&D group. www.apotex.com

The role reports directly to the company President in Montreal, Canada and is responsible for the two sites within the Niagara campus.

Some Key Highlights:
•Hosted successful regulatory and client audits/visits.
•Successfully conceived and implemented unique new product development projects.
•Gained licences and approvals by lasoning with Health Canada and FDA.
•Increased in-house lab testing capabilities thereby reducing incremental costs.

(JSP is a contract manufacturer of brand products from major pharmaceutical companies in N. America. The contact manufacturing capabilities include solid orals, liquids and topical. JSP sites were previously owned by Custom Pharmaceuticals, Patheon and Pharmetics. www.pharmetics.com

The role reports to VP Quality and is responsible for day today QA, Compliance, Audit activities of WellSpring sites (Oakville, Canada and Sarasota, US) and for contract manufacturing sites (Canada, US).

Some Key Highlights:
•Successfully hosted multiple FDA, Health Canada and Clients GMP Audits.
•Responsible for the smooth tech transfer and launch of newly acquired brand products in a short timeline (Kalamazoo, US).
•Conducted several GMP audits as part of vendor maintenance program and developed industry rapport.
•Implemented an efficient CAPA tracking and follow-up system (Solab).
•Introduced innovative GMP training program linking WellSpring daily operations to GMP regulation sections.

(WellSpring’s focus is in development, marketing and sales of novel prescription and OTC drugs. The company is involved in contract manufacturing and Clinical projects as well. WellSpring's prescription products include Dyrenium, Dibenzyline..; OTC’s include well known brands such as Gelusil, Colace, Micatin, Emetrol, Dequadin, Mucomyst. WellSpring site was previously owned by Searle, Roberts and Shire. www.wpcoutsourcing.com; www.wellspringpharm.com

The role reports to Operations VP and is responsible for the QA, Compliance and Audit activities of Vita Health Site in Winnipeg, MB. The role has the additional responsibility of managing the finished product contract manufacturers in India, US and S.Korea on behalf of Corporate (Leiner Health, Carson, California, US)

Some Key Highlights:
•Successful regulatory audits with the lowest ever # of citations for the company.
•Implemented the Annual Product Review program.
•Conducted numerous GMP audits based on US/Canadian GMP’s as part of corporate CMO site management.

(Canada’s largest private label manufacturer of Natural Health and OTC products. Vita Health is a contract manufacturer for major pharma companies. Vita Health was part of Leiner Health, US. www.vitahealth.ca

The role at Patheon is reporting to QA Manager with key responsibilities of product release, QA SME and investigation review.

Some Key Highlights:
•Identified by the management consultant-Carpedia as the top contributor for QA product release activity.
•Involved in key product development projects of various international clients.

(Patheon is the leader in pharmaceutical contract manufacturing and development with 14 facilities in North America and EU. Patheon, Whitby site was involved in contract manufacturing for major US, UK, East-European, Middle-East and Asia-Pacific pharma clients. The site was previously owned by Novartis. www.patheon.com

TECHNICAL SERVICES (QUALITY & RA) at A&A PHARMACHEM-IPG-MARCAN, Ottawa, Canada

The role was primarily created to gain regulatory approval (product and site) for importation of finished pharmaceuticals in addition to supporting existing API patent, regulatory submission and QA activities. The role directly reports to President of the company.

Some Key Highlights:
•Procured multiple DIN numbers for imported generic pharmaceutical products.
•Gained site license and NOC for finished product importation.

(A & A is a major Canadian importer and distributor of pharmaceuticals products, bulk formulations and raw materials, who work with customers for product approvals. A & A’s contract manufacturing partners supplied finished and semi-finished formulations (DC granules) to renowned pharmaceutical firms. www.aapharmachem.com; www.ipgenerics.com; www.marcanpharma.ca

The role reports directly to company Managing Director and is responsible for the large volume, small volume parenteral, solid dose and medical devices manufacturing operations within the site.

Some Key Highlights:
•Lead internal auditor and Management Representative for the ISO 9000: 2001 audits.
•Successfully commissioned powder injection lines.
•Procured licenses in regulated markets by completing product registration dossiers.

(KPL is involved in the manufacturing of sterile products (large volume parentrals- IV fluids & small volume parentrals), eye drops, eardrops and medical disposables. The firm was a contract manufacturer for international suppliers of sterile products. The plant is GMP and ISO certified. www.kokadpharma.com

The role reported to Manager, Validation. The two member team was responsible for the IQ/OQ, PPQ, Media Fill, Sterilization Validation, Challenge Studies, CSV, PLC, Facility Qualification activities and audit support of Solid Dose, Injectable, Oncology and Biotechnology sites of Intas.

Some Key Highlights:
•Received award for being instrumental in the modification of the pure steam generator system design.
•Potentially appraised and recommended for higher responsibilities.
•Key team member for successful MHRA, TGA, MCC, Anvisa, MCAZ, MoH Algeria, WHO audits.

(The site has approvals from US FDA, MHRA (MCA), TGA, MCC. Intas oncology plant is within the same campus. It has presence in 42 countries. Intas capabilities include solid orals, sterile small volume, oncology, biotech and a CRO called Astron Research. Intas is a contract manufacturing site for major US, UK manufacturers including erstwhile Schering-Plough. www.intaspharma.com)