Position Details
- Role: Junior Team Member – Quality Control (QC)
- Location: Rangpo, Sikkim, India
- Division: Quality
- Department: Quality
- Employment Type: Permanent
Job Purpose
The primary objective of this role is to prepare, update, and review specifications, SOPs, policies, and operational documents required for material analysis, ensuring strict adherence to predefined quality parameters, regulatory standards, and cGMP requirements.
Key Accountabilities
- Documentation Preparation:
- Develop and maintain SOPs, specifications, and other relevant documents.
- Ensure timely availability of documentation to support material analysis.
- Pharmacopeial Compliance:
- Stay updated on pharmacopeial changes, supplements, and amendments.
- Evaluate and implement necessary updates in documentation to maintain compliance with current pharmacopoeia.
- Document Review and Compliance:
- Review documents against pre-defined quality procedures.
- Ensure compliance with regulatory and quality requirements.
- Document Issuance:
- Issue documents to relevant units, maintaining records in an issuance logbook.
- Ensure the current version of common documents is accessible at all units.
- Harmonization and Simplification:
- Streamline and standardize processes to reduce complexities.
- Implement harmonized procedures across the QC department.
Qualifications
- Education: M.Sc. or B.Pharm
- Experience: Minimum 2 years in the QC department of a pharmaceutical organization.
Required Skills and Competencies
- Core Competencies:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Technical Skills:
- Strong domain knowledge in Quality Control and cGMP.
- Familiarity with regulatory standards and pharmacopoeial compliance.
- Soft Skills:
- People management abilities.
- Strong analytical and organizational skills.