Job Description

ROLE SUMMARY

summarize the primary purpose & key accountabilities of the role. Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.

• Shall be responsible for carrying out the Calibration activities for various instruments

ROLE RESPONSIBILITIES

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 key result areas that highlight accountability and level of judgment required.

Key Areas

Activities

Equipment qualification

• Generation and revision of specifications (URS)
• Collaborate with CFTs for URS/DQ/IQ/OQ and PQ of all relevant equipment
• Provide onsite support in start-up and commissioning of new equipment or upgrades to existing equipment on aspects

Equipment Maintenance

• Study and review standby facilities for critical sub-assemblies and addition of capital equipment on long term basis for smooth operation
• Effective communication with original equipment manufacturer to address / resolve the repetitive issues.
• Maintain oversight over the state of calibration across the block
• Ensure inspection readiness in calibration across the block
• Prepare calibration schedule for instruments
• Provides expert support for troubleshooting in calibration of manufacturing equipment and utility system instrumentation
• Calibration Contractor Management
• Perform routine field inspections of calibration status labelling to ensure compliance to the global requirements.
• Contribute to best practices within the Pfizer network on calibration
• Identify the calibration service providers and provide support in qualifying them.
• Trend the breakdowns /concerns of the equipment and implement corrective actions to improve the reliability of the equipment.

Project Management

• Contribute to continuous process improvements initiatives
• Provide technical guidance and support of new projects in specifying new instruments and calibration methods for projects

Reporting

• Prepare monthly reports
• Publish metrics reports on calibration, on-time performance and alert on open issues.

Documentation/Compliance

• Change Control Management
• Achieve and maintain required standards in calibration and instruments across the site
• Develop, implement and maintain calibration procedures
• Provide support to the site in reviewing the potential product impact due to an out-of-calibration situation
• As requested, present and support the calibration program during internal and external audits.
• Handling any Deviations/Incidents
• Preparation and Review of respective Documents

Cultural Attributes

• Conduct himself/herself in line with the Pfizer Values; Courage, Equity, Excellence & Joy

Statutory Obligations

• Conduct himself/herself in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.

Environmental Health and Safety

• Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
• Ensure that all safety instructions and measures are strictly observed.

ESSENTIAL REQUIREMENTS

Determines the education, experience and competencies that a person needs to have in order to do the job effectively

Preferred Education/ Qualification (Eg. Diploma, Certificates, bachelor's degree, Master's Degree, licenses, technical certification)

Graduate / Diploma Engineer in Electronics and Instrumentation Engineering / Electrical and Electronics Engineering / Computer Engineering with specialization in Instrumentation

Experience (type and length of experience needed to perform effectively)

6-8 yrs of experience for Diploma engineers (4-6 yrs for Graduate engineers) with practical experience in calibration

Core Competencies (refers to skills, knowledge and attributes that an employee must possess to be competent in the position

Detailed knowledge of the following:

• Maintenance of PLCs, DCS, SCADA and various Electronic field instruments and sensors
• Operation and maintenance of pharmaceutical equipment
• Knowledge of commonly used equipment and machines in pharmaceutical industry
• Knowledge of qualification concepts - URS/DQ/IQ/OQ and PQ.
• Operation of pharmaceutical machinery
• Calibration procedures, tools and processes
• Calibration database systems
• Experience in implementing standardization procedures and processes

Standards, Processes & Policies

• Basic HSE and GMP/QA knowledge
• Knowledge on Clean room requirements, behavior, Good documentation work and Regulatory Guidelines
• Knowledge on metrological standards
• Standard instruments
• Global calibration policies

DESIRABLE REQUIREMENTS

Identify the 'nice to haves'. These are not critical but would be advantageous.

Advanced Competencies (Up to 5 advanced competencies can be list)

• Documentation Preparation and review skills
• Effective problem-solving capabilities
• Excellent Interpersonal, written and communication skills
• Effective coordination between departments

Additional Desirable Requirements (may be experiences, courses, skills etc)

None

DECISION MAKING SCOPE

Describes the level of authority the employee has in the areas of financial, colleague and policy/procedures.

Staffing (Responsibilities such as recruitment, training, performance reviews, coaching)

(for people managers only)

? Recruitment ? Performance Review

? Training ? Coaching ? Not applicable

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Engineering

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