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Manager Qc

8-10 years
Not Disclosed
10 July 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Manager QC

Location: Baddi, India
Department: Quality


Job Summary

Join a leading pharmaceutical manufacturing facility in Baddi as a Manager – Quality Control (QC). This critical role is responsible for driving compliance, ensuring timely and accurate documentation, leading analytical validations, and supporting audits and regulatory inspections. The ideal candidate brings strong knowledge of ICH, USP, pharmacopeial updates, and regulatory documentation within pharma QC operations.


Key Responsibilities

  • Manage QC documentation (Change Controls, SOPs, STPs, GTPs, Specifications) in compliance with regulatory and internal policies.

  • Review and approve SAP specifications to ensure alignment with regulatory standards.

  • Conduct risk assessments and feasibility analysis for pharmacopeial and regulatory updates.

  • Evaluate and implement QRI (Quality Risk Indicators) actions within timelines.

  • Lead analytical method validations and verifications per ICH/USP guidelines.

  • Coordinate QC activities for new product introductions and technology transfers.

  • Ensure timely and effective audit response and readiness for internal and external inspections.

  • Drive continuous improvement initiatives (Lean Lab, Opti-Q, method optimization).

  • Review and approve analytical reports for accuracy and compliance.

  • Manage training compliance in ISOTrain and maintain updated training records and matrices.


Required Skills & Qualifications

  • Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, or related discipline.

  • Minimum 8–10 years of experience in QC within pharmaceutical manufacturing.

  • Expertise in ICH guidelines, pharmacopeial standards (USP, BP, IP), and SAP specifications.

  • Proven experience in analytical method validation and audit management.

  • Proficiency in QMS tools and ISOTrain for training compliance.

  • Strong documentation, regulatory interpretation, and problem-solving skills.


Perks & Benefits

  • Competitive salary and performance-based bonuses

  • Exposure to global quality systems and international regulatory standards

  • Professional development through continuous training programs

  • Safe and compliant work environment adhering to cGMP and GxP principles

  • Opportunities for cross-functional collaboration and advancement


Company Description

Join one of India’s premier pharmaceutical manufacturing facilities known for delivering high-quality formulations and maintaining global standards in quality assurance and compliance. With a robust quality system and focus on continuous improvement, the company supports innovation and regulatory excellence.


Work Mode: On-site (Baddi, Himachal Pradesh)


Call to Action

Ready to elevate your career in Quality Control with a global pharma leader? Apply now and be part of a team committed to delivering excellence in pharmaceutical manufacturing.