(Provide a brief summary of the primary purpose of this role)
Responsible for managing the manufacturing of solid dosage forms of tablets and capsules. Manufacturing Manager ensures that the Standard Operating Procedure’s guidelines and company policies are readily available and met by the Manufacturing Supervisor and operators. Ensure the manufacturing operators are in compliance with the cGMP requirements.
Key Duties & Responsibilities:
(Briefly describe the essential activities that are performed by this role including key duties/responsibilities. Each statement should start with a verb. Additionally, indicate how frequently it is performed)
Manage and coordinate with Quality Assurance and Quality Control on all Production activities.
Manufacturing Manager ensures that the Standard Operating Procedure’s guidelines and company policies are readily available and met by the Manufacturing Supervisor and operators.
Ensure the manufacturing operators are in compliance with the cGMP requirements.
Maintain required documentation as per cGMP guidelines of the FDA.
Responsible for all operation employees’ training.
Coordinating all shift schedules.
Plan, coordinate, troubleshoot and procure all the tools necessary and support the manufacturing operators in achieving the productivity targets.
Ensures that the team leaders are adhering to all safety procedures and identifying/communicating the necessary adjustments to address potential safety concerns. The Manager will also ensure the Supervisor/ team leaders are enforcing the proper wearing of PPE (personal protective equipment).
Identifies employee development needs based upon personal assessment and feedback from Supervisor/ team leaders.
Supports and develops a comprehensive continuous and structured training program for the site.
Works with production teams to ensure that goals are being met.
Maintains primary communication of performed goals and requirements as identified by production management.
Focuses on driving productivity improvements while maintaining high quality standards.
Initiates/supports revision and approval of Batch Manufacturing Records and SOP’s.
Supports attainment of Supervisor/team leaders’ goals.
Works collectively with production, customer service and other necessary areas to ensure timelines are met and results are achieved.
Writes deviations/investigations and performs root cause analysis to formulate an effective CAPA plan.
Other duties as assigned.
Typical Supervisory Responsibility:
(Identify any responsibilities the role has for supervising others)
Leadership skills which reflect directives for compliance of all pharmaceutical products.
Education & Experience:
(Describe the education required for this role, including specifications, if any. If equivalent experience or knowledge can be substituted for the educational requirements, A combination of Education and experience shall be taken into account.)
Specialization (If any)
Bachelor Degree preferred
(Describe the experience required for this role. Identify the type of experience, number of years, and any additional comments on the experience and education requirements for the role. Also, include any geography specific requirement that differs from the experience.)
Number of Years
(Minimum to Maximum)
Technical competencies/ Certifications/ Licenses:
(Briefly describe the required competencies such as, skill, ability, knowledge an individual must possess to perform the role. Also, identify any certification or licenses required to perform the role.)
· 10 + years of experience in pharmaceutical industry preferred
· Must be able to read, write, and communicate in English as well
· Must have leadership skills
· Accuracy reporting to SYSPRO
· Accuracy reporting to batch records
· Entering information in log books for DEA, and FDA purposes
· Must be a critical thinker with a “can do” attitude, and be able to think “outside the box”.
· Process troubleshooting
· Some understanding of IQ, OQ, and PQ
· Handle and complete special projects as required
· Other duties as required or delegated
· Document all performed analysis as per cGMP, USFDA and 21CFR211.194 guidelines.
· Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170.
· Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.
· Follow all DEA (Drug Enforcement Agency) guidelines
· Computer literate with basic knowledge of Microsoft Office
· Basic knowledge of an Inventory reporting system, e.g., SYSPRO, JDE, SAP, Vantage
KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs. We take pride in our ability to advance medical care and offer low-cost alternatives in response to today’s healthcare challenges.
Our continued success lies in the skills, business expertise, and dedication of our people in maintaining the highest manufacturing standards and providing exceptional customer service. Our commitment to quality, affordability, and integrity resonates throughout our entire business operation.