Executive - Quality Control

1 week ago

Navi Mumbai, Maharashtra, India Piramal Enterprises Full time ₹ 9,00,000 - ₹ 12,00,000 per year
Job Overview

To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards.

Roles and Responsibilities:

  • Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC.
  • Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable.
  • Perform method validation, verification, and transfer in line with ICH guidelines.
  • Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols.
  • Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations.
  • Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation.
  • Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule.
  • Prepare samples and documents for regulatory submissions and audits (e.g., DMF support, ANDA filings).
  • Coordinate with QA, RA, Production, and R&D for timely resolution of issues and release of batches.
  • Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc.) and internal quality audits.
Experience –4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry
Competencies
  • Hands-on experience with instruments like HPLC, GC, UV-Vis, and others.
  • Sound understanding of cGMP, GLP, and regulatory guidelines
  • Strong documentation and communication skills.
  • Ability to work in shifts and under pressure.
  • Team player with problem-solving and analytical skills.

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

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