This Manager provides direction and leadership to Quality Control Operations Maintenance and Safety departments. This role supports corporate objectives through continuous improvement in machinery practices and procedures that improve safety results maintain consistently high product quality standards reduce product costs and enhance employee satisfaction.
Ensure effective Product Safety environment with adherence to FDA cGMP UL Certification and all other agreed upon product safety requirements.
Responsible for maintaining plant federal state and local regulations.
Provide the leadership that supports our Quality Systems inclusive of efforts regarding Customer Required Systems.
Provide sound budgeting and planning for the manufacturing and support operations.
Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
Develops strategies and programs that improve the productivity and efficiency of various work processes of the company.
Keeps management team abreast of significant issues or developments identified during activities and actions being taken to improve the situation.
Establish operating indicators (metrics) which clearly measure departmental performance on a regular basis and communicate this information to upper management and critical customers.
Responsibilities for supervising direct reports include: hiring and training planning assigning and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems.
Ensure effective personnel orientation training and development programs.
Foster an environment of open communications and trust with all employees.
Facilitates employee teams to build cohesiveness and improve the overall results of the respective teams tasks.
Manage CAPEX projects and budget planning.
Perform annual facility registration on FDA.
Follow up on audit status.
Point person for FDA audits.
Develop and implement corrective action and preventative actions (CAPAs) for audit observations nonconformance and or plant issues involving quality.
Council Laboratory and Plant personnel concerning work issues.
Design and conduct required training for pharmaceutical program: Annual current good manufacturing practice new or revised master batch documentation addressing audit observations CAPA and nonconformance etc.
Schedule annual pharmaceutical training for key plant personnel.
Perform product reformulation based on product history and knowledge.
Perform pharmaceutical product reformulation based on customer request and pharmaceutical guidelines.
Continually review and audit pharmaceutical program to assure conformance with pharmaceutical guidelines.
Responsible for quotations and capital expense projects concerning laboratory.
Manage Management of Change process and documentation concerning pharmaceutical program.
Requisitos
- Instruction: Chemical Bachelor degree or Chemical Engineering. Specialized Graduation courses / MBA in related areas.
- Experience: Production manufacturing operations processes quality e maintenance.
- Type of experience: (I): Experience in analytical laboratory management experience with current good manufacturing practices (cGMP); FDA requirements. (II): Experience in the area of operations; Production and people management; Production costs (variable and fixed); Participation in projects and knowledge in safety and environment (indicators methodologies and analyses).
- Skills: Leadership Critical Capacity Flexibility Customer and Business View Persuasion Decisions Make Good Communication Good Interpersonal Relationship Ability to decide plan change management Creativity & innovation work in multifunctional teams work under pressure. Prioritization decision analytical capacity systemic view negotiation Customer people and EHS.
Instruction: Chemical Bachelor degree or Chemical Engineering. Specialized Graduation courses / MBA in related areas. Experience: Production manufacturing operations, processes, quality e maintenance. Type of experience: (I): Experience in analytical laboratory management, experience with current good manufacturing practices (cGMP); FDA requirements. (II): Experience in the area of operations; Production and people management; Production costs (variable and fixed); Participation in projects and knowledge in safety and environment (indicators, methodologies and analyses). Skills: Leadership, Critical Capacity, Flexibility, Customer and Business View, Persuasion, Decisions Make, Good Communication, Good Interpersonal Relationship, Ability to decide, plan, change management, Creativity & innovation, work in multifunctional teams, work under pressure. Prioritization, decision, analytical capacity, systemic view, negotiation, Customer, people and EHS.