Assistant General 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 Adva Gen 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

Position Overview:

As a team leader for AMV, the candidate will be responsible to lead a team of more than 15 scientists, overseeing mainly the analytical method validation activities along with RM and PM verification and documentation.

Key Responsibilities:

Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Also responsible for RM & PM characterization and documentation.
Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained.
Represent as the subject matter expert for lifecycle management of analytical assays, equipment and materials including in process samples and finished products.
Responsible for answering the analytical queries before and after submission with regulatory department and external regulatory authorities.
Review of DMF for outsourcing API and preparation and follow up of review reports.
Responsible for setting of product specifications and Methods, and Preparation of various justifications.
Reply and justification to internal quality audits.
Responsible for support to Regulatory and plant QC requirements.
Skilled with Handling of Incident, change control associated with in department.
In Support for Investigation of OOS, OOT in quality control department. Also periodically perform internal Audit and carry out Internal quality compliance Training.
Exceptionally well organized and detail-oriented with capability to meet deadlines.
Holds competencies in implementing various quality standards and techniques for improving the project operations along with cost savings.
An effective communicator with excellent relationship building & interpersonal skills; strong analytical, problem solving & organizational capabilities.
Coordinates findings with the team to generate conclusions.
Coordinates system maintenance and calibrations to ensure minimum downtime.
Ensure GLP compliance in the laboratory and to make lab audit ready all the times.
To provide any technical support to plant and ensure all QC required documents are provided in time.
To discuss with formulation leads on all project related activities to ensure timely delivery of the products.
To ensure timely availability of material budget for initiation of product development and validation
To prepare and review the Capex for analytical department.

Key Qualifications &

Experience:

M. Pharm / M. Sc. / Ph.

D.
Knowledge of management of spphisticated analytical instruments like HPLC, GC, LC-MS, GC-MS, ICP-MS etc.
Awareness of regulatory guidances
Knowledge of QMS

Additional notes:
Candidate is expected to work in any of the shifts based on the requirement (need based).
Candidate is expected to visit external sites as per the project requirements.