Quality Control Senior Executive

Job Title: Senior Executive - Quality Control

Location: Mehsana, Gujrat

About [Company Name]:

Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter/manufacturer based in India. The company provides it products and services in multiple countries globally including West Africa, East Africa, South Asia, South East Asia, the Middle East, South America & Europe. Apart from promoting our branded products in the retail sector, we also participate in a number of global tenders in a number of countries. The team comprises of a group of first generation marketing expats and some of the best technocrats in the field. The company has four manufacturing bases in India, manufacturing a variety of products.

This job posting is in a hormone formulation manufacturing division of Celogen Pharma.

Job Summary:

The Senior Executive - Quality Control will be a key member of our Quality Control team, responsible for ensuring the highest standards of quality for our pharmaceutical products, from raw materials to finished goods. This role involves the execution and oversight of various analytical tests, data review, documentation, and active participation in laboratory investigations and continuous improvement initiatives. The ideal candidate will have a strong background in pharmaceutical QC, excellent analytical skills, and a thorough understanding of cGLP guidelines.

Responsibilities:

 Analytical Testing:

· Perform routine and non-routine analytical testing of raw materials, in-process samples, finished products, stability samples, and packaging materials using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, KF, Dissolution, Titration, Physical testing).

· Ensure all testing is conducted in accordance with approved pharmacopoeial methods and in-house specifications.

· Operate, calibrate, and maintain analytical instruments, ensuring their optimal performance and readiness for testing.

 Data Review & Documentation:

· Thoroughly review analytical data, raw data, and laboratory notebooks for accuracy, completeness, and compliance with established procedures and regulatory requirements.

· Prepare and review Certificates of Analysis (COAs) and other relevant quality documents.

· Ensure timely and accurate documentation of all testing activities, results, and observations.

· Maintain detailed and organized laboratory records.

 Investigations & Deviations:

· Participate in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, identifying root causes and recommending corrective and preventive actions (CAPAs).

· Document and investigate laboratory deviations, ensuring adherence to established procedures.

· Support the implementation and verification of CAPAs.

 Method Development & Validation Support:

· Assist in the development, transfer, and validation of analytical methods as per regulatory guidelines.

· Conduct feasibility studies and provide technical input for method optimization.

 Compliance & Audits:

· Ensure strict adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable regulatory guidelines (e.g., FDA, MHRA, WHO).

· Participate in internal and external audits (e.g., regulatory inspections, customer audits) by providing necessary documentation and technical support.

· Address audit observations and implement corrective actions.

 Training & Mentorship:

· May assist in training junior QC analysts on analytical techniques, instrument operation, and laboratory procedures.

· Serve as a technical resource for other team members.

 Safety & Housekeeping:

· Comply with all laboratory safety procedures and guidelines.

· Maintain a clean, organized, and safe working environment.

· Manage laboratory waste in accordance with environmental regulations.

 Continuous Improvement:

· Identify opportunities for process improvements and efficiency enhancements within the QC laboratory.

· Contribute to the revision and creation of Standard Operating Procedures (SOPs) and other quality documents.

Qualifications:

· Education: Bachelor's or Master's degree in Pharmacy, Analytical Chemistry, Chemistry, or a related scientific discipline.

· Experience: 5-8 years of progressive experience in Quality Control within a pharmaceutical manufacturing environment.

Skills & Competencies:

· Proficient in operating and troubleshooting a wide range of analytical instruments (HPLC, GC, UV-Vis, FTIR, KF, Dissolution apparatus, etc.).

· Strong understanding of analytical method validation and transfer principles.

· Experience with LIMS (Laboratory Information Management System) is highly desirable.

· Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

· In-depth knowledge of cGMP, GLP, and regulatory requirements (e.g., ICH guidelines).

· Excellent analytical, problem-solving, and critical thinking skills.

· Strong attention to detail and accuracy.

· Ability to work independently and as part of a team in a fast-paced environment.

· Excellent written and verbal communication skills.

· Strong organizational and time management skills.

· Experience with specific pharmaceutical dosage forms (e.g., tablets, capsules, injectables, liquids).

· Familiarity with Data Integrity principles.

· Certification in Six Sigma or Lean Manufacturing is a plus.

Job Type: Full-time

Work Location: In person

Expected Start Date: 15/07/2025