Director- Production

MedImmune
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At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Making the impossible a reality can mean taking a chance on an idea and investing in our exceptional capacity for innovation and discovery. We champion trying new things, and we nurture a test and learn culture that means we are always progressing close to our goals. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.

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).

Responsibilities

Production Management

  • 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

BPR/BOM management

Right First Time artwork on packaging components delivered to market

  • Ensure compliant artwork design;

People management & leadership

  • 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.

Project management

  • 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 AZ guidelines e.g. financial, GMP, SHE

SHE responsibility

  • 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

Quality Overview

  • 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.

Competencies

  • Thorough understanding of GMP, pharmaceutical process, quality management and regulatory requirements
  • Continuously invest time and effort to gain new skills and knowledge required to succeed in the work and involve in innovation actively

Leadership Capabilities (AZ Leadership target level)

  • AZ leadership capability target level 3

Accountabilities (As per AZ framework)

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance,Team Management, Performance Management, Individual Development Planning,Talent Management, Recruitment, People information, SHE accountabilities, and

Fiscal and Financial awareness.

Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

Key Working Relationship

  • Manufacturing Science and Technology (MS&T)
  • Product stewardship team (PAR&D)

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

Desirable

  • 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

People Management Responsibility

  • 60-80 Approximate number of indirect reports

Salary: Competitive ​

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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More Information

Type

Executive / senior industry position

Karn%C4%81l%2C%20India

Karnāl , India

Location

India

Karnāl

Type

Executive / senior industry position

Karn%C4%81l%2C%20India