Specialist – Quality Operations

Major accountabilities:

·       Coordination and management of analytical method transfers and stability studies. Compilation of data reports

·       Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints

·       Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc

·       SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.

·       Validate spreadsheets

·       Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)

·       Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc

·       Trend and report all QMS elements as per the request

·       Monitor, trend and report Health Safety and Environmental parameters

·       Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).

·       Perform activities of a Quality Control expert as defined by the respective sites

·       Support regulatory requirements – routine queries, Chromatogram requests

·       Compile Quality performance management decks

·       Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed

Key performance indicators:

·       On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration  

Minimum Requirements:

·       Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute

·       Min 3 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices

·       GxP knowledge, Basic IT knowledge

·        Good communication, presentation and interpersonal skills

·       Experience of working closely with the global stakeholders

Skills:

·       Continuous Learning.

·       Dealing With Ambiguity.

·       Gmp Procedures.

·       Qa (Quality Assurance).

·       Quality Control (Qc) Testing.

·       Quality Standards.

·       Self Awareness.

·       Technological Expertise.

·       Technological Intelligence.

Languages :

·       Fluent in English (written and spoken)