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Director - Production
Line Manager Job Title
Brief Job Description
The director of Production is accountable for leading a multi- disciplinary team and accountable for the overall performance of all processes of production, material & asset utilization and supplies to next supply chain customer.
He/ She is also accountable for process development, improvement, establishment and validation (including cleaning validation); equipment/ systems qualification and validation; packing artwork design (including anti-counterfeit), site risk management and development of technical/ project management skills across the site.
He/She ensures that the function operates within all required guidelines, procedures and compliance standards (SHE, financial, GMP etc).
Education, Qualification and Experience
Academic / Professional qualification: University graduate, major in pharmaceutical or related subjects
Technical/ skills training: Pharmaceutical knowledge including production and regulatory process; technology transfer/ NPI; validation and GMP knowledge
Working experience: 5 plus years’ practical experience in pharmaceutical production and/or quality management and/or technical management during which at least 3 years in management position
Computer and Language: Good computer and English communication skills
Cross-functional working experience in engineering, project management, etc
15 plus years of production management or technical management or quality management experience in reputed pharmaceutical companies
Accountable for all manufacturing process related activities and ensure that the products meet quality specifications and the needs of customers;
Develop production objectives and KPIs and fulfil it without compromise;
Work with QA, Supply Chain, Engineering, etc. to guarantee smooth & safe run of production operation;
Plan and implement manpower & expense budget, investment budget, align with site development plan;
Establish continuous improvement initiatives in the areas of quality, productivity, cost reduction, efficiency & effectiveness, safety and environment;
Ensure compliance with all relevant regulations and Global guidelines;
Approval of instructions relating to production operations and to ensure their strict implementation;
Ensure that all the required training of the personnel is carried out according to need;
Authorize written procedures and documents;
Monitor and control the manufacturing environment;
Monitor and assess the in-process controls;
Ensure compliance with the requirements of Good Manufacturing Practice;
Site validation status management
Ensure the site’s validated status is maintained to a compliant standard (including equipment, systems and processes, such as, process improvements / changes, change to parameters, API / excipient, etc);
As appropriate, review and approve site policies, guidelines, protocols, program, reports, etc, associated with qualification and validation of systems, processes and equipment
Ensure BPRs and BOMs are kept up to date, compliant and accurate
Right First Time artwork on packaging components delivered to market
Ensure compliant artwork design;
Ensure appropriate anti-counterfeit measures are included in the designs
People management & leadership
Accountable that the department’s organization is built and developed in alignment to the site's development;
Build, lead and motivate the team to achieve stretch goals;
Recruit qualified staff according to organizational development needs and provide professional training & coaching;
Establish challenging individual objective and development plan of staff. Determine assignments and do performance appraisal of staff in accordance with the company policy;
Communicate company policies & decisions within the function and ensure they are well understood and followed by staff;
Develop manager’s and supervisor's professional & leadership capability through coaching, delegation and providing high- level training program etc.
Initiate and lead any production & continuous improvement related project or site level project according to business need
As functional head in general
Set & deliver budget & headcount targets;
Develop suitable level of technical expertise
Ensure that the function consistently works within all guidelines e.g. financial, GMP, SHE
Act as a SHE steering committee member and promote SHE within the area of responsibility and ensure that SHE considerations are incorporated into all activities;
Review SHE performance and provide advice and recommendation;
Support and guide improvements on SHE performance within the function;
Ensure adequate resources are allocated to SHE issues
Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation.
Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through participation in management reviews and through advocating continual improvement.
People Management Responsibility
5-8 Approximate number of direct reports
60-80 Approximate number of indirect reports