QP Compliance Scientist

Why REMEDICA

Remedica is a leading pharmaceutical company with a vision for a healthier world through high quality, safe and efficacious products at affordable prices.

We are looking for:

A Compliance Scientist for are QP team to review Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), for compliance with the registered Marketing Authorizations and relevant regulatory requirements. The role involves ensuring adherence to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDocP), and company procedures to develop QP core competencies.

As a Compliance Scientist you will:

• Conduct thorough reviews of Batch Manufacturing and Batch Packing Records (BMRs / BPRs) to ensure completeness, accuracy, and compliance with company standards and regulatory expectations.
• Ensure all documentation complies with Good Documentation Practices (GDocP), maintaining clarity, accuracy, and traceability of records
• Collaborate with Regulatory Affairs and Quality Assurance teams to ensure accurate implementation of Marketing Authorizations within manufacturing documentation.
• Perform batch documentation review on behalf of the company's Qualified Persons as part of the QP release process
• Assist in audits conducted by regulatory authorities and customers, providing documentation and support as required.
• Prepare and submit detailed reports on review outcomes to the Qualified Person(s).
• Support the preparation and verification of Certificates of Conformance (CoC) for batch release.
• Draft, revise, and maintain SOPs, reports, and other quality-related documentation in accordance with internal and regulatory standards
• Undergo structured training and mentoring programs designed to develop core competencies required for QP eligibility, in accordance with applicable EU and national regulations.
• Gain hands-on exposure and understanding of Quality Control operations, including sampling, testing, equipment qualification, method validation, and laboratory data review.
• Develop a robust understanding of pharmaceutical manufacturing processes across production's areas.
• Build in-depth knowledge of product lifecycle management, change control, deviations, CAPA, risk assessments, and quality metrics.
• Participate in cross-functional activities including material release, stability program oversight, and supplier qualification to build a comprehensive QP-level perspective.
• Identify and recommend improvements to documentation review processes and compliance practices.

What you will bring:

• Bachelor's Degree in Pharmacy
• Proficient in English language
• Prior experience in the pharmaceutical industry, preferably in a QA, QC, or manufacturing environment.
• High attention to detail and good documentation practices (GDP).
• Strong communication, organization, and analytical skills.
• Proficient in Microsoft Office (Word, Excel, Outlook).
• Critical Thinking
• Team-oriented, adaptable, and proactive.
• Able to work under fast paced situations

What's in it for you?

• 13th and 14th salary
• Provident Fund
• Group Medical Plan
• Discount scheme

If you are interested you can apply via our website:
QP Compliance Scientist Job Details | Remedica Limited