Quality Officer - Biotechnology (Secunderabad)

Quality Officer - Biotechnology (Secunderabad)

24 Oct
|
ProPharma
|
Secunderabad

24 Oct

ProPharma

Secunderabad

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D; technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Change Control, Deviations, Quality Events (QEs), CAPAs, Effectiveness Checks, etc.)
Participate in GxP change management activities including risk and impact analysis review, change plan review and approval, action plan implementation, and tracking to completion, as applicable.
Support client audits and regulatory inspections processes (including questionnaires):
Track audit and inspection records in eQMS to closure.
Generates and prepares reports to communicate outcomes of quality activities.
Analyzes and investigates Deviations and QEs to identify areas for improvement in the quality system.
Collection, management, and analysis of data related to CAPAs, Deviations, QEs, and quality KPIs.
Medical Information specific:
Retrospectively evaluates telephone skills and case reports to ensure compliance standards are met and maintained.
Fluent in English speaking and writing.
Knowledge and experience in working with GXP Quality Management Systems.
Proficient computer skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).




Exceptional organization, prioritization, project management and delegation skills; Excellent attention to detail and focus on quality.
Excellent verbal, written, and interpersonal communication skills with the ability to establish strong professional relationships with quality and internal staff, and with clients.
Exceptional customer service skills within quality and internal staff, and with clients.
Adaptable and proactive toward changing needs.
University/bachelor's degree and/or appropriate relevant work experience.

Experience Requirements
Minimum 2 years of experience working in a Quality Assurance role.
Deviation, Quality Event, CAPA, Effectiveness Check handling experience preferred.
Knowledge and experience in working with GxP Quality Management Systems including but not limited to record management, reporting, and data analytics.
Medical Information QA - experience assessing telephone calls in a call center is preferred.
We are committed to diversity, equity, and inclusion. We do not rely on AI screening tools to support our hiring process. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***Please, no phone calls or emails to anyone regarding this posting.***

📌 Quality Officer - Biotechnology (Secunderabad)
🏢 ProPharma
📍 Secunderabad

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