Associate, Validation (Contract)

Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.

Reaching People. Touching Lives.

Job purpose

The primary purpose is to generate, execute, modify and summarize validation documents for equipment, facilities (manufacturing and laboratory), manufacturing processes, cleaning and sanitizing processes at SunPharma Canada’s manufacturing site that may affect the quality of the product produced or tested. This is accomplished through interaction and co-ordination of activities with all relevant departments within the organization.

Duties and responsibilities

• Write Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process). Ensure protocols provide:

1. a high degree of assurance that a specific equipment or process will consistently produce a product meeting predetermined specifications and attributes,
2. assurance of the establishment of controls required by current Good Manufacturing Practices (cGMP).

• Responsible and accountable for the execution of Validation Protocols including:

1. observation and documentation of the equipment or process,
2. collection of samples,
3. coordination of testing and
4. coordination of third party services.

• Write reports that summarize and assess impact of the results generated through the Validation Protocols. Where required, recommend corrective measure(s) with the objective of attaining validated status.
• Perform equipment and process validation reviews as required.
• Write or revised Validation related SOP’s or Policies as required.
• Evaluate new equipment from a validation perspective through participation on the equipment selection team with engineering to ensure that new purchases will be capable of meeting validation requirements.
• File and maintain Validation documentation archive ensuring prompt document retrieval when required.
• Manage effectively all assigned Validation projects.
• Establish strong relationships inter- and intra-departmentally.
• Work proactively with other departments to ensure Validation requirements are met.
• Complete all GMP Documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Train SunPharma personnel on protocol execution requirements as necessary.
• Participate in and/or lead Non Conformance Investigations, as necessary
• Complete Corrective and Preventive Actions (CAPA’s)
• Initiate, and follow through with actions required to close Change Controls
• Other duties as assigned.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Bachelor’s degree in Natural Science or Engineering (mechanical or chemical preferred).
• Minimum 2 years of pharmaceutical or relevant technical experience.
• Strong project management and communication /writing skills
• Proficient computer skills and broad technical knowledge are required in order to provide value-added input into the Protocol development and execution process and to understand and analyze technical systems (mechanical, electrical & scientific).
• Knowledge of the principles and application of current Good Manufacturing Practices guidelines related to Validation activities is essential, as is the ability to work both independently and in a team to achieve objectives
• Knowledge of Change Control Systems.
• Exceptional verbal and written communication skills
• Innovative mindset combined with strong problem solving ability.
• Problem Solving:

• The ability to schedule and prioritize workload to meet Validation Master Plan requirements and apply resource in the most productive and efficient manner.
• Interact with relevant departments to assemble necessary documentation to support Validation activities.
• Assess impact of system changes (e.g., modify process) and recommend additional validation testing as necessary.
• Create new or revise testing procedures to satisfy Protocol requirements.

Working conditions

• Occasional exposure to chemicals and higher or lower than normal temperatures.
• On occasion flexible hours of work may be required to support Validation Protocol execution.
• Some lifting may be required. Some travel to support equipment factory acceptance testing may be required. Routinely a mixture of standing/walking/sitting are required

Physical requirements

Variety of working environments including all areas of the office and plant.

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $63,500 to $79,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. Employees are eligible to participate in Company employee benefit programs which include medical, dental coverage and the employee assistance program. Contract employees also receive vacation pay and paid sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

The Company uses artificial intelligence to screen, assess or select applicants.

Notice to Agency and Search Firm Representatives:   Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.  Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun.  No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.