Quality Control Laboratory Manager
4 weeks ago
Title: QC- Chemist
Company: Sinterx Pharma Private Limited
Location: Valigonda, Choutuppal.
Position Description:
The QC Chemist with 5 to 8 years of experience is responsible for leading and executing complex analytical testing of API intermediates to ensure compliance with predefined quality standards and regulatory guidelines. This role includes conducting advanced testing, reviewing analytical data, supporting investigations, mentoring junior analysts, and contributing to continual improvement initiatives. The QC Chemist plays a key role in maintaining product quality throughout the production lifecycle by collaborating closely with Quality Assurance, Production, and R&D teams.
Educational Background:
Bachelor’s or Master’s Degree in Chemistry, Pharmaceutical Sciences, or Life Sciences
Work Experience:
- 5 to 8 years of experience in Quality Control within the API or API Intermediate manufacturing industry
- Hands-on experience in instrumental analysis (HPLC, GC, UV, IR, KF, etc.) and wet chemistry techniques
- Strong understanding of regulatory guidelines (GMP, ICH, FDA, etc.) and data integrity practices
Key Responsibilities:
- Perform routine and non-routine analysis of raw materials, intermediates, and in-process samples using validated methods and instruments.
- Conduct instrumental analysis using HPLC, GC, UV, FTIR, KF, and ensure proper calibration and maintenance.
- Review and interpret analytical data, ensure compliance with internal specifications and regulatory standards.
- Identify and investigate deviations, OOS/OOT results, and support CAPA implementation in collaboration with QA.
- Lead or assist in method validation, method transfer, and stability studies for intermediates.
- Ensure strict adherence to GMP, GLP, and ALCOA+ principles in all documentation and laboratory practices.
- Maintain and review laboratory documentation including test records, logbooks, equipment usage logs, and analytical reports.
- Support internal and external audits by preparing necessary documentation and responding to audit findings.
- Provide technical support and training to junior analysts, ensuring adherence to safety, quality, and compliance standards.
- Collaborate with Production, QA, AR&D, and Regulatory Affairs for continuous improvement and troubleshooting.
Required Skills:
- Advanced analytical and problem-solving skills
- Proficiency in handling and troubleshooting analytical instruments (HPLC, GC, etc.)
- In-depth knowledge of ICH guidelines, GMP regulations, and data integrity principles
- Strong documentation and reporting abilities
- Ability to work independently and as part of a cross-functional team
- Experience in investigation and risk assessment processes
- Familiarity with LIMS, Empower, or similar laboratory data systems (preferred)
Key Attributes:
- Detail-oriented with a focus on data accuracy and compliance
- Good communication and interpersonal skills
- Ability to handle multiple tasks and meet deadlines in a fast-paced environment
- Commitment to continuous learning and process improvement
If you are Interested in the job Position, forward your resume to hr@sinterxpahrma.co
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