What are the responsibilities and job description for the Operations Supervisor position at Jobskey Consultancy?
Primary Responsibilities:
Education and Experience:
- Plan, organize and oversee all activities related to the manufacturing and packaging of MDIs to include batch planning, operations, troubleshooting and shift personnel management.
- Review and compile the documents generated during the production of MDIs such as batch records and protocols (i.e. validation protocols, qualification protocols, etc.).
- Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing and packaging operations.
- Evaluates various stations of the production operation to ensure optimum efficiency and follow through.
- Initiate and review written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures as needed.
- Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches.
- Coordinate with departments such as Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Maintenance & Engineering, Supply Chain and Warehousing, Human Resources, and other internal functional partners with respective to the completion of quality work and achieving the production schedules and performance objectives.
- Ensure the process flow of raw materials, supplies, and other resources.
- Provide daily supervision and support to operators in daily production activities such as trouble shooting and other work tasks.
- Follow production schedules, ensures quality standards, and handle technical and administrative issues on assigned shift.
- Maintain communication between employees and upper management to ensure procedures and policies are understood.
- Assist with recruiting, hiring, training, motivating, and evaluating the performance of a diverse manufacturing team.
- Manage performance and train assigned employees using Company systems, procedures, policies, practices, and other tools to meet established performance standards, productivity targets, and overall business requirements.
- Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures.
- Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
- Documents production by completing forms, reports, logs, and records of equipment and batches.
- Update job knowledge by participating in training opportunities.
- Maintain accurate and clear documentation that proves that manufacturing is being carried out in accordance with both internal and external quality systems or regulations.
- Keep maintenance logs for all of the machines or processes they oversee, which requires proficiency in word processing and spreadsheet software.
- Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
- Other duties as assigned.
Education and Experience:
- Bachelor’s degree in Pharmaceutical engineering, Pharmaceutical Sciences or related field of study from an accredited college/university required.
- Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
- 1-3 years of direct work experience in pharmaceutical manufacturing.
- Technical Knowledge and Computer Systems Skills
- Understanding of machines used in pharmaceutical manufacturing.
- Capable of conducting troubleshooting, investigations and root cause identification and analysis.
- Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
- Must be proficient in computer skills and software applications such as Microsoft Office tools.
- Experience using SAP business system and applications is a plus.
- Experience in Inhalation products (MDI) is a plus.
- Professional and Behavioral Competencies
- Proficiently speak English as a first or second language
- Ability to understand and analyze complex data sets.
- Knowledge of statistical packages is a plus.
- Knowledge of good manufacturing practices and good documentation practices preferred.
- Ability to read, write and communicate effectively.
- Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
- Excellent organizational skills with the ability to focus on details.
- Basic computer skills (Word and Excel) – Intermediate
- Good basic math knowledge and excellent attention to details.
- Work Schedule and Other Position Information:
- Must be willing to work in a pharmaceutical manufacturing setting.
- Must be willing and able to work any assigned shift ranging from first, second, or third shift.
- Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
- Must be willing to work some weekends based on business needs as required by management.
- Relocation negotiable.
- No remote work available.
- No employment sponsorship or work visas.
