Pharmaceutical Plant QA- QC Executive/ Officer

Pharmaceutical Plant QA- QC Executive/ Officer Axia Global

Education: Master of Technology/Engineering (Bio-Chemistry, Bio-Technology), Master of Science, Master of Pharmacy

Nationality: Egyptian, Indian, Jordanian, Lebanese

Gender: Female

Benefits: Annual Air Ticket, Annual Bonus, Medical Insurance, Travel Allowance, Visa

Vacancy:

Job Description: As part of a greenfield pharmaceutical manufacturing setup, the Executive – QC & Micro will play a key role in establishing and maintaining the quality control processes for the new facility. The plant will focus on the production of pharmaceutical formulations, such as tablets, syrups, and ointments, adhering to global regulatory standards. The incumbent will ensure the delivery of high-quality products by performing advanced microbiological and chemical testing, maintaining compliance with cGMP, and supporting regulatory requirements.

KEY RESPONSIBILITIES:

1. Perform routine and non-routine microbiological, chemical and environmental testing of raw materials, intermediates, and finished products.
2. Conduct sterility testing, microbial limit tests, endotoxin testing, and water analysis.
3. Manage stability studies as per approved protocols.
4. Ensure all QC activities comply with cGMP, GLP, and regulatory standards, including local UAE Ministry of Health regulations.
5. Maintain accurate and detailed documentation, including test results, validation reports, and logbooks.
6. Prepare, review, and implement standard operating procedures (SOPs) relevant to QC and microbiology.
7. Ensure calibration of QC instruments such as HPLC, GC, UV-Vis spectrophotometer, FTIR, and microbiology-specific instruments like autoclaves, incubators, and particle counters.
8. Perform periodic validation and qualification of laboratory instruments.
9. Support internal and external audits by regulatory authorities.
10. Ensure readiness for inspections and address audit observations in a timely manner.
11. Work closely with Production, QA, and R&D teams to resolve quality issues.
12. Investigate Out of Specification (OOS) and Out of Trend (OOT) results and implement corrective and preventive actions (CAPA).
13. Conduct routine environmental monitoring of clean rooms and controlled areas.
14. Trend analysis of environmental monitoring data and implementation of necessary actions to mitigate risks.
15. Provide training to junior staff on QC and microbiological techniques.
16. Stay updated on advancements in QC and microbiological methodologies and implement them as applicable.

Desired Candidate Profile:

Bachelors/master’s degree in microbiology, Pharmacy, Chemistry, or a related field.

5-7 years of experience in Quality Control and Microbiology within the pharmaceutical industry, preferably in a greenfield project or similar setup.

Key Skills:

1. Proficiency in analytical and microbiological testing techniques.
2. In-depth knowledge of regulatory requirements such as cGMP, GLP, ICH guidelines, and UAE Ministry of Health regulations.
3. Hands-on experience with QC instruments and microbiology equipment.
4. Strong documentation and problem-solving skills.
5. Effective communication and teamwork abilities.
6. Strong analytical and critical thinking skills.
7. Ability to work under pressure in a fast-paced environment.
8. Adaptability to new systems and procedures in a greenfield setup.
9. Commitment to maintaining high-quality standards.
10. Cultural competence and ability to work in diverse teams.