Research Associate – Bioanalytical QA | Wockhardt

Biopractify

Chhatrapati Sambhajinagar District

Presencial

INR 700 000 - 900 000

Tempo integral

14 dias+

Gerador de candidaturas

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Resumo da oferta

Wockhardt is seeking a Research Associate – Bioanalytical QA to contribute to regulated bioanalytical research activities, quality systems, and compliance within a pharmaceutical R&D environment.

The ideal candidate holds an M.Pharm with 2–6 years of relevant experience in bioanalytical QA, familiar with GLP/GDP, SOPs, and CAPA processes to ensure accuracy and traceability in study data and documentation.

Qualificações

M.Pharm degree from a recognized institution.
2–6 years of relevant professional experience in bioanalytical research, quality assurance, pharmaceutical R&D, or related field.
Knowledge of GLP, GDP, SOPs, quality systems, CAPA, deviations, investigations, and regulatory compliance.
Strong documentation, analytical, auditing, communication, and problem-solving skills.

Responsabilidades

Bioanalytical QA audits across study phases to ensure GLP/GDP and regulatory compliance.
Prepare, review, and approve quality documents including SOPs, manuals, protocols, reports, logbooks, and study data.
Manage issuance and archival of raw data forms and laboratory logbooks with proper documentation and traceability.
Review and support quality systems related to method validation, change controls, deviations, CAPA, investigations, and regulatory deficiencies.
Assist with regulatory and corporate audits, audit responses, and activities maintaining quality standards.

Conhecimentos

GLP

GDP

SOPs

Quality Systems

CAPA

Investigations

Regulatory Compliance

Auditing

Documentation

Analytical Skills

Communication

Problem-Solving

Formação académica

M.Pharm

Descrição da oferta de emprego

Research Associate – Bioanalytical QA | Wockhardt

Company: Wockhardt

Position Available: Research Associate – Bioanalytical QA

Wockhardt R&D is inviting applications for the position of Research Associate – Bioanalytical QA. This opportunity is ideal for professionals with experience in bioanalytical research and quality assurance who are looking to contribute to regulated research activities, quality systems, and compliance within a pharmaceutical R&D environment.

What You’ll Work On

Bioanalytical & Statistical Study Audits

Conduct audits across bioanalytical and statistical study phases to ensure compliance with study protocols, SOPs, GLP, GDP, and applicable regulatory requirements.

Quality Documentation

Prepare, review, and approve quality documents including SOPs, manuals, protocols, reports, logbooks, and study data.

Data & Record Management

Manage the issuance and archival of raw data forms and laboratory logbooks, ensuring proper documentation and traceability.

Quality Systems

Review and support quality systems related to method validation, change controls, deviations, CAPA, investigations, and regulatory deficiencies.

Regulatory & Corporate Audits

Assist with regulatory and corporate audits, audit responses, and activities related to maintaining compliance with applicable quality standards.

Ideal Candidates

You hold an M.Pharm degree from a recognized institution.

You have 2–6 years of relevant professional experience in bioanalytical research, quality assurance, pharmaceutical R&D, or a related field.

You possess knowledge of GLP, GDP, SOPs, quality systems, CAPA, deviations, investigations, and regulatory compliance.

You have strong documentation, analytical, auditing, communication, and problem-solving skills.

What You’ll Gain

Opportunity to work with Wockhardt R&D in a bioanalytical research environment.
Hands-on exposure to bioanalytical quality assurance and regulated research processes.
Experience with quality systems, audits, documentation, CAPA, and regulatory compliance.
Professional growth opportunities within the pharmaceutical R&D sector.