Analytical QA Role at Syngene – Apply Online
Title: Reviewer – Analytical QA
Date: 28 Oct 2024
Job Location: Bangalore
Pay Grade: 9-II
Years of Experience: 3 – 6 Years
Job Description
Job Title: Reviewer – Analytical QA
Job Location: Bangalore
Reporting Grade: Senior Executive
About Syngene:
Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is fundamental to our operations. This commitment is reflected in shared responsibility and accountability for following safety guidelines, procedures, and SOPs with diligence.
Mandatory Expectations for All Roles as per Syngene Safety Guidelines
- Overall adherence to safe practices and procedures for oneself and aligned teams.
- Contributing to the development of procedures, practices, and systems ensuring safe operations and compliance with the company’s integrity & quality standards.
- Promoting a culture focused on environment, health, and safety (EHS) at the workplace.
- Ensuring the safety of self, teams, and lab/plant by adhering to EHS protocols at all times.
- Completing all assigned mandatory training related to data integrity, health, and safety promptly.
- Complying with Syngene’s quality standards consistently.
- Holding self and teams accountable for achieving safety goals.
- Regularly reviewing safety metrics.
Core Purpose of the Role:
- Responsible for the review of all GMP analytical documents generated at the Early Phase Laboratory (@S17) for 24×7 support. The AQA reviewer will assist S14 & S18 production in A, B, and Night shifts for in-process, raw material, and finished product review and release.
- Responsible for the review and approval of analytical documents in ELN, LIMS, and SAP.
- Conduct periodic audit trail reviews for all standalone analytical systems and Chromeleon software.
Role Accountabilities:
- Manage QA activities related to Stability Center QC Late Phase Stability and Early Phase GMP Laboratory.
- Review analytical documents from Stability Center QC and Early Phase GMP Laboratory, ensuring activities align with approved procedures.
- Assess data generated at the Stability Center for correctness, authenticity, completeness, and data integrity per the Data Integrity policy.
- Complete required training and qualifications before performing activities.
- Review raw data, online sequences, chromatograms, method parameters, integration, and calculations.
- Perform review/approval-related activities in LIMS, ELN, and SAP.
- Issue logbooks, documents (annexures, ODS, calibration sheets, log sheets), and allocate instrument numbers and format numbers.
- Conduct regular GMP rounds in the laboratory.
- Coordinate and participate in customer/third-party, cGMP, regulatory, and internal quality audits, ensuring compliance with observations.
- Report any discrepancies to the reporting manager or GMP Analytical Laboratory head/designee.
- Contribute to developing procedures, practices, and systems for safe operations and compliance with quality standards.
Leadership Capabilities:
- Work effectively with cross-functional teams.
- Provide quality support aligned with QC and production work plans.
Syngene Values
All employees will consistently demonstrate alignment with our core values:
- Excellence
- Integrity
- Professionalism
Specific Requirements for This Role
Experience:
- 3 – 6 years’ experience in the pharma industry as an analyst or reviewer.
Demonstrated Capability:
- Strong knowledge of chromatograms, non-chromatographic techniques, and all analytical techniques in the pharma industry.
Education:
- M.Sc. (Chemistry) or M. Pharma
Skills and Capabilities
- Proficient in analytical knowledge.
- Strong understanding of chromatographic & non-chromatographic techniques, including HPLC, GC, IR, UV, NMR, XRD, ICPMS, GCMS.
- Comprehensive knowledge of data integrity compliance and pharmacopeia guidelines (USP, EP, ICH).
