Position Location: GSS, Hyderabad, India Position Title: Senior Associate – Quality-APQR & Stability Reports to: GSS – Manager –Quality APQR
MAJOR DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
The Senior Associate will work with the Quality Manager of the Shared Services team and is responsible for supporting team deliverables/mandates. The individual hired will be expected to foster an environment of continuous improvement and assist/participate in initiatives that enhance operational efficiency and control.
Review, analyze and/or interpret data to generate the related documents and reports.
Perform activities related to APQR’s:
Data Trending: Collect Quality parameter data , use statistical tools (excel, other tools), calculate trends.
Report Drafting : Use templates and prepare APR report for review to the senior associates or to the team manager
Tracking : Use calendar, schedules by sites and ensure the APRs are made ready
Manage deadlines with efficiency and a high level of accuracy on assigned projects. Must manage multiple deadlines and communicate concerns as deemed necessary
Review the work and activities done by the team members
Mentor junior level team members, while facilitating training and feedback
Act as Quality Manager back up as designated.
Perform activities related to Stability:
Should assist in managing and maintaining stability documentation as part of GSS-QA team which involves supporting stability studies, ensuring documentation compliance, and helping with data entry, writing stability protocols, writing and organizing stability reports and verification of stability reports.
Collaborate with site stability teams to ensure timelines are met for timely pull out, analysis and in documentation & report submissions.
Summary of functions
Data analysis and technical reports writing.
Act as subject matter expert across the Shared Services Quality department
Follows Curia Global Quality policies and procedures.
Desired Skill Set:
Strong attention to detail and analytical acumen
Regulatory knowledge and Quality Systems Knowledge
Ability to follow manuals and guidelines to complete tasks
Process Knowledge & Technical writing
Results Focus
Ability to analyze data and see a trend/pattern
Willing to work in shifts, depending upon job requirement
Proficiency in Microsoft Excel is a must
Knowledge of Minitab is preferred
Basic understanding of Six sigma principles and methodologies will be considered an asset
Qualification and Experience:
B.S./B.A. or M.S. degree in Chemistry, Microbiology, Chemical Engineering or related field.
6-9 years of experience in the pharmaceutical industry (commercial manufacturing sites within API or DP), with at least 2 of those years being experience in Quality Assurance
Experience of Shared Services strongly preferred (dedicated unit for the execution of specific operational tasks for the multiple business units within the organization).
Strong knowledge of the pharmaceutical industry regulations applicable to API and Drug Product manufacturers.
Good understanding on Good Manufacturing Practices, with practical experience on the field.
Demonstrated experience in Quality data tracking, trending, and any statistical tools i.e. Minitab.
Language/Communication Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write and review reports, business correspondence, and procedure manuals.
Knowledge of another language (Spanish, Italian or French) would be considered as an asset.
