PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide.
An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.
Due to a constant growth, PQE is looking for a new Laboratory Specialist, willing to join our PQE US Consultants team.
MAIN AREA OF EXPERTISE
- Execution of Cleaning Validation sampling & testing (e.g. HPLC, UV, TOC)
- Laboratory samples management
- Perform investigation of Laboratory OOS/deviations/discrepancies
- Data Integrity in Laboratory environment
- Technical Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering)
- Minimum of 2-3 years' experience in the Pharmaceutical industry
- Laboratory Testing execution to support cleaning validation program implementation
- Provide technical support to cleaning activities associated with the manufacturing process as needed
- Interpret, and evaluate analytical data in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, etc...)
Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working.
- Proficient time management skills, planning and organization capabilities.
- Proven teamwork skills, results-oriented and build and maintain strong relationships with multiple groups.
- Proven analytical and problem-solving skills.
- Proficient in cGMP's, OSHA and FDA Regulations as it applies to the pharmaceutical industry.
- Full availability to travel domestically and abroad: up to 70%
NICE TO HAVE
- Project management Skills
- Operational Excellence skills
- English (fluent): mandatory
• Other languages: nice to have
Job Type: Full-time