Nourish Pharmaceutical Walkin On 17th October – 26 October  For Quality Assurance Executive

1. Prepare and review Validation Master Plans to outline comprehensive strategies and frameworks for validating various processes, equipment, facilities, and systems in accordance with regulatory requirements and industry best practices.

2. Prepare and meticulously review a range of product validation protocols, including Process Validation, Hold Time Study, Analytical Method Validation, Stability Study, and Cleaning Validation protocols, along with their detailed and comprehensive report formats.

3. Participate in planning validation activities and coordinate with other departments to ensure that validation activities are carried out as planned and that samples are collected and handed over to the QC Department.

4. Collect the required reports from QC, verify them, and attach them to the Process Validation Report.

5. Responsible for compiling and reviewing validation activities, including all necessary documents such as protocols, filled reports, certificates of analysis, BMR, and BPR.

6. Responsible for preparing and reviewing Equipment and Instrument Qualification protocols, including detailed documentation such as User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, along with comprehensive Performance Qualification reports. These essential protocols and reports are subjected to periodic reviews to confirm compliance, and actively engaging in Performance Qualification tasks, including requisite instrument calibrations. The compilation of thorough documentation ensures the adherence of equipment and instruments to the organizational quality assurance framework.

7. In charge of drafting utility qualification protocols for critical systems like Water, HVAC, Compressed Air, and Area Qualification, ensuring these protocols are regularly updated and documented in accordance with Good Manufacturing Practice (GMP) guidelines and industry standards. These meticulously compiled reports serve as evidence that all utilities align with regulatory requirements within the manufacturing plant’s operational framework.

8. Conduct regular assessments of current validation programs and ensure the punctual execution and fulfillment of qualification tasks, including periodic qualifications for facilities, equipment, utilities, and processes. Coordinate validation efforts across various departments to ensure timely completion and adherence to industry regulations. Work closely with cross-functional teams throughout validation processes, providing quality supervision and expert guidance to secure successful outcomes.

9. Prepare and follow the calibration calendar program, liaising with external agencies to ensure timely completion of calibration activities, and collect and review calibration certificates to promptly compile them in their respective files.

10. Ensure that the qualification and calibration status of equipment and instruments are displayed visibly and accurately, with detailed labeling for easy identification and tracking purposes.

11. Responsible for preparing and reviewing the QA department’s SOPs, logbooks, and registers.

12. Responsible for preparing the validation activity training module and accountable for providing training on shop floor activities related to protocol and report filling.

13. Participate in and support internal and external audits by providing requested documentation and ensuring continuous audit readiness.

14. Stay updated on industry regulations and best practices related to document management and issuance.

Required Skills

• A strong understanding of current Good Manufacturing Practices (cGMP) is vital for maintaining quality standards.
• Ability to maintain detailed records and organize documentation for audits and validation processes.
• Proficient use of tools such as Excel, Word, and 365 for reporting and managing validation documentation.
• Communication and Teamwork: Effective communication skills for working within cross-functional teams and documenting processes clearly.

Qualifications

• A Bachelors degree in Pharmacy, Chemistry, or a related field provides the necessary foundation in scientific principles and industry knowledge required for the role.

Experience

• 3-5 years in pharmaceutical quality assurance and validation.