Manager Analytical Method Validation

Company Overview:

Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.

Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US.

We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms.

Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA.

For additional information visit www.rubicon.co.in

Position Overview:

The candidate shall have the role of manager in Analytical method validation to support end to end activities related to validation activity and respective documentation for different regulatory markets.

Key Responsibilities:

• Ensure the first-time right documents for Analytical method validation activity and successful transfer at site.
• Responsible for planning the daily activities for the Analytical method validation.
• Co-ordination with the Analytical development team to ensure timely availability of all pre-requisites required for validation.
• Responsible for review of protocols & reports for analytical method transfer.
• Responsible for initiation, execution & approval of all incidence, investigations Change Control, Deviations, CAPA etc.
• Ensure to follow the quality management system activity during the execution of validation activity.
• Responsible to impart and identify training need identification to AMV personnel as and when required.
• Support the CMO's projects for timely completion.
• Documents updation based on the Guidelines/regulatory requirements.
• Handling of regulatory query data generation and response.
• Technical input to the team for analytical data generation.
• Addressing the plant analytical issue and support.
• Preparation of material budget.
• Ensure compliance in the laboratory.
• Technical training to team members.
• Having good knowledge of regulatory guidelines like US, UK, TGA, EU, ROW etc..
• Handling the teams with proper guidance to ensure and meet the target timelines.
• To review the documents through DMS system and follow the QMS system.
• To ensure that the analytical work carried out by team is complying to GLP, regulatory and quality expectations and is audit ready for ensuring superior standard of GLP to meet FDA expectations.

Key Qualifications & Experience:

• M. Pharm/M. Sc (Organic or Analytical chemistry)
• Instrument Knowledge of handling HPLC, GC, KF, , IC,PSD etc.
• Exposure in US, UK, EU, ROW regulatory bodies.
• Exposure to GDP to meet the regulatory requirement.
• Handling of Regulatory query.

Additional notes:

• Candidate is expected to work in any of the shifts based on the requirement.
• Candidates is expected to visit external sites as per projects requirements.