CELOGEN PHARMA PVT LTD

CELOGEN PHARMA PVT LTD

**Quality Control Head** **Location:** Mehsana, Gujarat **About Company:** Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter and manufacturer based in India. We provide products and services across multiple countries globally, including West Africa, East Africa, South Asia, Southeast Asia, the Middle East, South America, and Europe. Beyond promoting our branded products in the retail sector, we actively participate in global tenders across numerous countries. Our team comprises first-generation marketing experts and some of the industry's finest technocrats. With four manufacturing facilities across India, we produce a diverse range of pharmaceutical products. This position is within our hormone formulation manufacturing division. **Job Summary:** The Head of Quality Control (QC) is a senior leadership position responsible for directing all laboratory operations related to testing raw materials, packaging materials, in-process materials, and finished pharmaceutical products. This role ensures all quality control activities comply with current Good Laboratory Practices (GLP) and applicable national and international regulatory standards. The successful candidate will drive the strategic direction of the QC function, ensuring high-quality, timely analytical support for manufacturing and product release. **Key Responsibilities:** **Analytical Testing:** - Perform routine and non-routine analytical testing using various techniques (HPLC, KF, Dissolution, Titration, Physical testing) - Ensure testing complies with approved pharmacopoeial methods and in-house specifications - Operate, calibrate, and maintain analytical instruments for optimal performance **Data Review & Documentation:** - Review analytical data, raw data, and laboratory notebooks for accuracy and compliance - Prepare and review Certificates of Analysis (COAs) and quality documents - Maintain detailed, organized laboratory records with timely documentation **Investigations & Deviations:** - Lead Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations - Identify root causes and recommend corrective and preventive actions (CAPAs) - Document and investigate laboratory deviations following established procedures **Method Development & Validation:** - Support development, transfer, and validation of analytical methods per regulatory guidelines - Conduct feasibility studies and provide technical input for method optimization **Strategic Leadership & Management:** - Develop and execute long-term QC department strategy aligned with business objectives - Lead, mentor, and manage the QC team while fostering a culture of quality and continuous improvement - Oversee daily laboratory operations, including scheduling, resource allocation, and infrastructure management **Regulatory Compliance & Quality Systems:** - Ensure compliance with cGMP, GLP, and pharmacopoeial requirements (USP, EP, JP) - Serve as primary QC representative during regulatory inspections and audits - Review and approve critical QC documentation, including SOPs and validation protocols **Cross-functional Collaboration:** - Partner with Manufacturing, Quality Assurance, Regulatory Affairs, and R&D teams - Coordinate with QA to evaluate and monitor supplier material quality - Support process improvements and meet production deadlines **Required Qualifications:** **Education:** Bachelor's or Master's degree in Analytical Chemistry or Organic Chemistry **Experience:** 8-10 years of progressive experience in Quality Control within pharmaceutical manufacturing **Essential Skills & Competencies:** - Proficiency in analytical instruments (HPLC, GC, UV-Vis, FTIR, KF, Dissolution apparatus) - Strong understanding of analytical method validation and transfer principles - In-depth knowledge of GLP and regulatory requirements (ICH guidelines) - Experience with LIMS (Laboratory Information Management System) preferred - Proficiency in Microsoft Office Suite - Excellent analytical, problem-solving, and critical thinking abilities - Strong attention to detail and accuracy - Outstanding written and verbal communication skills - Proven organizational and time management capabilities - Experience with pharmaceutical dosage forms (tablets, capsules, injectables, liquids) - Familiarity with Data Integrity principles **Employment Details:** - Job Type: Full-time - Salary: ₹35,000 - ₹60,000 per month - Work Location: In-person - Expected Start Date: July 15, 2025

CELOGEN PHARMA PVT LTD

**Company Overview** Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter and manufacturer based in India, delivering products and services across multiple global markets including West Africa, East Africa, South Asia, South East Asia, the Middle East, South America, and Europe. Beyond promoting branded products in the retail sector, we actively participate in global tenders across numerous countries. Our team consists of first-generation marketing experts and distinguished technocrats in the pharmaceutical field, supported by four manufacturing facilities across India producing a diverse range of products. **Position Summary** We are seeking a detail-oriented Regulatory Affairs Specialist to prepare, submit, and maintain regulatory applications for pharmaceutical products throughout their lifecycle in designated markets. The ideal candidate will be a proactive professional with comprehensive knowledge of global regulatory guidelines, including ROW Markets and ICH requirements, with FDA and EMA knowledge being advantageous. **Key Responsibilities** **Regulatory Submissions & Documentation** • Prepare, coordinate, and review regulatory submissions, including dossiers, NODs, and tender submissions • Manage assembly and quality control of regulatory documents in CTD format • Ensure all submissions are accurate, complete, and meet regulatory timelines • Maintain and update regulatory files and databases to ensure data integrity • Prepare comprehensive Technology Transfer Documentation **Compliance and Strategy** • Monitor and interpret evolving regulatory guidelines, legislation, and industry standards • Communicate regulatory impacts to relevant internal stakeholders • Provide regulatory guidance to cross-functional teams including R&D, Clinical, Quality, and Manufacturing • Support development and implementation of regulatory strategies for product development and lifecycle management **Communication and Interaction** • Serve as primary regulatory contact for internal teams and external stakeholders • Coordinate and prepare responses to health authority inquiries and deficiencies • Represent Regulatory Affairs in internal and external audits and inspections **Qualifications** **Education** • Bachelor's degree in Pharmacy (required) • Master's degree in Regulatory Affairs (preferred) **Experience** • 3-5 years of experience in Regulatory Affairs within the pharmaceutical industry **Skills & Competencies** • Proven expertise in global regulatory requirements (ROW Markets, ICH) • Knowledge of FDA and EMA requirements advantageous • Exceptional attention to detail and strong organizational abilities • Excellent written and verbal communication skills **Employment Details** • Position Type: Full-time, Permanent • Compensation: ₹25,000 - ₹40,000 per month • Work Location: On-site