Job Description

Department

Quality Control

Designation

Executive / Sr. Executive – Quality Control

Reporting To

Section Head – Quality Control

Location

Ambernath, Maharashtra, India

Educational Qualification

Master’s Degree in Chemistry or Life Sciences

Experience

8–10 years of relevant experience in Peptide Quality Control or Pharmaceutical Industry

About Us

PolyPeptide Group is a specialized Contract Development & Manufacturing Organization (CDMO) focused on peptide- and oligonucleotide-based active pharmaceutical ingredients (APIs). With global GMP-certified manufacturing facilities across Europe, the U.S., and India, PolyPeptide supports pharmaceutical and biotechnology companies from pre-clinical development through commercial manufacturing while contributing to therapies that improve millions of lives worldwide.

Purpose of the Role

To support Peptide Quality Control operations through analysis, characterization, and quality assessment of synthetic peptides using LC-MS and related analytical techniques. The role involves analytical method development, troubleshooting, data interpretation, regulatory documentation, and ensuring compliance with GMP, GLP, and global regulatory standards.

Key Responsibilities

• Perform peptide purity and identity analysis using:

  • LC-MS

  • HPLC

  • UPLC

  • GC systems

• Conduct routine quality control testing of:

  • Raw materials

  • Intermediates

  • Finished peptide products

• Develop, optimize, validate, and transfer analytical methods for peptide QC analysis.

• Interpret chromatographic and mass spectral data for peptide characterization and impurity profiling.

• Troubleshoot analytical and instrument-related issues associated with LC-MS and related systems.

• Ensure calibration, qualification, and preventive maintenance of laboratory instruments and equipment.

• Prepare and review:

  • Analytical reports

  • Certificates of Analysis (COAs)

  • SOPs

  • Validation protocols and reports

  • Specifications and analytical documentation

• Ensure compliance with:

  • GMP

  • GLP

  • FDA guidelines

  • ICH guidelines

  • Internal quality standards

• Investigate:

  • OOS (Out of Specification) results

  • OOT (Out of Trend) results

  • Deviations and laboratory incidents

• Participate in root cause analysis, CAPA implementation, and risk assessment activities.

• Maintain accurate documentation and ensure data integrity practices as per regulatory requirements.

• Support internal audits, customer audits, and regulatory inspections while ensuring audit readiness.

• Coordinate with R&D, Production, QA, and cross-functional teams for smooth analytical operations and issue resolution.

• Ensure laboratory safety compliance and adherence to good laboratory practices.

Required Skills & Competencies

• Strong technical expertise in:

  • LC-MS

  • HPLC

  • UPLC

  • GC analytical techniques

• Good understanding of:

  • Peptide analysis and characterization

  • GMP and GLP requirements

  • FDA and ICH guidelines

  • Data Integrity practices

• Experience in analytical method development and validation.

• Strong troubleshooting and investigation skills for analytical instruments and laboratory deviations.

• Good documentation, technical writing, and data handling capabilities.

• Strong analytical thinking and problem-solving skills.

• High attention to detail with a quality-focused mindset.

• Effective communication and collaboration skills.

• Ability to work independently and manage multiple priorities in a GMP environment.

Preferred Attributes

• Experience in peptide manufacturing or peptide analytical characterization preferred.

• Exposure to regulatory audits such as USFDA, MHRA, EU GMP, or WHO audits will be an added advantage.

• Familiarity with laboratory software, chromatography data systems (CDS), or LIMS preferred.

• Self-driven professional with strong ownership and compliance orientation.

Why Join Us at PolyPeptide Group

At PolyPeptide Group, you will work at the forefront of peptide therapeutics — one of the fastest-growing and most innovative segments in the pharmaceutical industry. As part of a global CDMO organization, you will gain exposure to advanced analytical technologies, international quality standards, and collaborative global projects that contribute to life-saving therapies worldwide.