Packaging Operations Team Leader 1

at  Grifols Worldwide Op Ltd

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding
Within this role you are responsible for the coordination, operation and maintenance of the packaging lines in support of manufacturing requirements, and to ensure the process meets cGMP (current Good Manufacturing Practices) and company standards.

PHYSICAL REQUIREMENTS

• Ability to lift /move up to 50 pounds.
• Ability to sit or stand for extended periods - up to four (4) hours at a time.
• Ability to operate material handling equipment such as pallet jacks and forklifts.
• Manual dexterity to perform all job functions.
• Ability to gown and work in an aseptic/cleanroom environment.

WHAT YOUR RESPONSIBILITIES WILL BE:

• Set up, coordinate, regulate and troubleshoot packaging assembly line equipment in a biologics processing environment for plasma derived pharmaceuticals.
• Perform visual inspection of product vials in accordance with specifications.
• Manually, or with the help of material handling equipment, load, unload, palletize, and distribute materials and products.
• Adhere to procedures and practices and maintain compliance with applicable departmental, corporate, industrial standards and/or applicable health, safety and regulatory requirements of a competent regulatory body.
• Responsible for the accuracy and completeness of batch documentation and material reconciliation.
• Responsible for cleaning facilities and equipment and for ensuring packaging machineries are maintained in proper working order. Perform basic calibration, preventive maintenance and repair work.
• Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product.
• Maintain a quality presence to ensure compliance with all regulatory requirements.
• Maintain current knowledge of regulatory and industry standards.
• Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
• Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
• Provide guidance and hands-on training to peers and/or direct reports and ensure all training records are up to date and in line with training SOP’s.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Minimum of 1-3 years of related experience in a pharmaceutical, GMP, or EU regulated environment is required.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
• Strong organizational, analytical, and problem-solving skills with the ability to make
• structured decisions on a routine basis.
• Demonstrated ability to inspire high performance in others and align team members around shared goals.
• Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop
• department personnel.
• Comprehensive knowledge and understanding of cGMPs, EU regulations, and industry guidelines highly preferred.
• Excellent verbal and written communication skills in the English language.
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, Powerpoint).
• Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation