SCS HR is looking for a Quality Control Manager to join a Pharmaceutical company based in Iraq. The Quality Control Manager will be accountable for driving results in a fast-paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures. The Quality Control Manager will lead and manage the Analytical and Microbiology groups for the manufacturing plant. Responsibilities include the technical oversight of compendial and non-compendial testing and technical writing. The position requires strong leadership behaviors as well as the functional competencies of this profile.
• Oversees execution of analytical testing including routine analysis, method transfer, suitability or method verification as needed.
• Responsible for assessing conformity of the tested materials and products as per specifications according to international and national requirements
• Responsible for the selection, training and development, coaching/mentoring, engagement, retention and performance management of a high performing team to meet the current and evolving needs of the site.
• Monitors equipment/instrument operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.
• Monitors quality of the group and optimizes efficiency of the work environment.
• Provides technical support and troubleshooting support as needed.
• Manage the company's environmental monitoring, stability program and critical utilities monitoring program in all GMP aspects.
• Ensures adherence to department, site and corporate SOPs and other regulatory requirements (GMP, GLP..).
• Conducts investigations individually and in conjunction with quality assurance.
• Effectively communicates with departments and internal groups.
• Participates in Quality audits as requested.
Minimum Desired Qualifications:
• Bachelor’s or Master’s degree (Chemistry, Biology, Microbiology) required.
• 3+ years of related pharmaceutical laboratory experience in a cGMP environment required.
• 2+ years of supervisory experience preferred.
• Knowledge of pharmaceutical microbiology testing, analytical testing, and quality principles in a cGMP environment.
• Knowledge of raw material, in-process and finished product testing, e.g. Microbial Limit Tests, Endotoxin, Sterility, utility testing, ID, appearance, cleaning methods, HPLC, TOC, conductivity and osmolality (or some combination).
• Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting required.
• Expert knowledge of cGMP.
• Excellent leadership, communication and presentation skills.
• Excellent skills in strategic planning, problem solving, root-cause analysis and critical thinking required.