Quality Specialist

ProPharma; Hyderabad; Hybrid; INR 600,000 - 900,000; Full time

Benefits offered by this job

Hybrid work model

Equal Opportunity Employer

Job summary

ProPharma in Hyderabad, India seeks a Quality Assurance professional with 2+ years of experience to support GxP compliance and eQMS activities. The role involves handling deviations, CAPAs, QEs, and audit support, ensuring data integrity and timely reporting, while collaborating with cross-functional teams.

Candidates should have a bachelor’s degree in a related field and strong communication skills in English.

Qualifications

• Fluent English communication, both written and verbal.
• Experience with GxP quality management systems and record-keeping.
• Proficiency in MS Office and data analysis basics.

Responsibilities

• Maintain awareness of and ensure compliance with GxP guidelines and regulations.
• Support eQMS activities including Change Control, Deviations, QEs, CAPAs and Effectiveness Checks.
• Develop, review and communicate root cause analyses and CAPAs to stakeholders.
• Perform effectiveness checks on Deviations and QEs and track CAPA closure.
• Coordinate audit readiness, client audits and regulatory inspections processes.
• Manage audit CAPA responses with SME support and track records in eQMS.
• Prepare reports communicating outcomes of quality activities.
• Analyze data related to CAPAs, Deviations, QEs and QA KPIs.

Skills

Fluent in English

GXP Quality Management Systems

MS Office proficiency

Strong organization

Attention to detail

Communication skills

Education

Bachelor's degree in Life Sciences / QA / related field

Tools

Microsoft Office

Job description

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. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.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.

Essential Functions:

• Maintain awareness of, and ensure compliance with, theGxPguidelines and regulations relevant to the services provided.

• Supports and facilitates eQMS activities (i.e., Change Control, Deviations, Quality Events (QEs), CAPAs, Effectiveness Checks, etc.)

• Develop, recommend, andmonitorDeviations,QEsand CAPAs. Review, approve, and communicate root cause and CAPAs to stakeholders.

• Perform effectiveness checks on Deviations and QEs todetermineefficacy of CAPAs.

• Participate inGxPchange management activities including risk and impact analysis review, change plan review and approval, action plan implementation, andtracking tocompletion, as applicable.

• Support client audits and regulatory inspections processes (including questionnaires):

• Coordinate and finalization of agenda, document provision; ensuring internallogisticsand Subject Matter Expert (SME) are in place.

• Coordinate and manage audit CAPA responses including developing responses to CAPAs with support from relevant internal SMEs.

• Track audit and inspection records in eQMS to closure.

• Ensuring audit information ismaintainedand stored in eQMS.

• Generates and prepares reports to communicate outcomes of quality activities.

• Analyzes and investigates Deviations and QEs toidentifyareas for improvement in the quality system.

• Collection, management, and analysis of data related to CAPAs, Deviations, QEs, and quality KPIs.

• Medical Informationspecific:

• Retrospectively evaluates telephone skills and case reports to ensure compliance standards are met andmaintained.

• Other duties as needed.

Necessary Skillsand Abilities:

• Fluent in English speaking and writing.

• Knowledge and experienceinworking with GXP Quality Management Systems.

• Proficient computer skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

• Exceptional organization, prioritization, projectmanagementand delegation skills; able to multitask.

• Excellent attention to detail and focus on quality.

• Excellent verbal, written, and interpersonal communication skills with the ability toestablishstrong professional relationships with quality and internal staff, and with clients.

• Exceptional customer service skills within quality and internal staff, and with clients.

• Ability to build positive collaborations with other departments and be open to change.

• Works in a professional manner with clients, teammembersand management.

• Flexible and proactive toward changing needs.

• Proactive with the ability to work with minimal supervision.

Educational Requirements:

• University/bachelor’s degree and/orappropriate relevantwork experience.

Experience Requirements:

• Minimum 2 years of experience working in a Quality Assurance role.

• Deviation, Quality Event, CAPA, Effectiveness Check handling experience preferred.

• Preferred: Knowledge and experience in working withGxPQuality Management Systems including but not limited to record management, reporting, and data analytics.

• Medical Information QA-experienceassessing telephone calls in a call center is preferred.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you’re successful or not.

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.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.