Investigator, Deviations

Sun Pharmaceutical Industries, Inc.; Brampton; On-site; CAD 73,500 - 92,000; Full time

Benefits offered by this job

Annual performance bonus

Medical, dental, and vision coverage

RRSP savings plan

Paid time off including vacation and S

Job summary

Sun Pharmaceuticals Industries, Inc. is seeking a Compliance Investigator to support regulatory requirements and ensure timely completion of investigations and complaints.

You will lead deviation investigations, root-cause analyses, and CAPA actions, coordinating with production, QA, and vendors while maintaining documentation in TrackWise and other systems. Strong writing and communication skills are essential.

Qualifications

• B.Sc. degree in Chemistry/Chemical Engineering or related STEM required.
• 3 years of experience in investigations, deviation reports, CAPAs, and change control in pharma/GMP.
• Knowledge of cGMP, GLP, FDA and Health Canada guidance and regulations.
• Good analytical, writing and communication skills.

Responsibilities

• Ensure investigations and non-conformances are handled in a timely, compliant manner.
• Lead investigations and write deviation, complaint, CAPA, and change control reports.
• Collaborate with SMEs, Production, QA, and Management to meet timelines.

Skills

Investigation writing

Root cause analysis

Problem solving

Interpersonal skills

Written and verbal communication

Technical report writing

Ability to work fast-paced

Attention to detail

Education

B.Sc. degree in Chemistry/Chemical Engineering or related STEM

Tools

TrackWise

MES Document Management System

Microsoft Office

Job description

Driven by abold pursuit of scienceand fueled byan 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 toReach People and Touch Lives, we deliverInnovative Medicines, Generics and Consumer Healthcare productsthat improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, weimprove access to effective, affordable treatmentsthat promote better health and well-being.

Reaching People. Touching Lives.

Job purpose

The main responsibility for this position is to provide compliance support to meet Sun and Regulatory requirements and ensure that all activities related to investigations and complaints are completed thoroughly and in a timely manner.

Duties and responsibilities

• Accountable to ensures that all activities related to the recognition, investigation and resolution of non-conformities are performed on a timely manner and in compliance with company and regulatory requirements.
• Leads and writes Deviations/Non-Conformances investigation reports
• Facilitate meetings with multiple Subject Matter Experts (SME’s) as required.
• Perform thorough impact analysis in collaboration with all SMEs including Vendors.
• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations.
• Regularly review on-going progress on all open investigations with Production Investigations team, QA approver team and Production Management team to ensure all timelines are attainable.
• Escalate any roadblock/issues which may pose the risk for meeting the investigation timelines.
• Prepare clear, accurate and concise investigation reports and review the reports for completeness and accuracy prior to approval by Department Manager
• Works closely with Production Managers and Release Teams to ensure investigations are closed within timely manner.
• Supports the CAPA and Customer Complaints programs as requested by Manager.
• Identifies and trends recurring Deviations /Non-Conformances and ensures appropriate actions are taken such as Management and Regulatory Notifications
• Creates training related to CAPA, Root Cause Analysis and production investigations to Sun employees’ personnel as required.
• Develops or assists with Change Controls and SOP’s as required.
• Participates in the internal audit program.
• 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

• B.Sc. degree in a Chemistry/Chemical Engineering stream or related STEM discipline.
• Three (3) years of experience conducting investigations and writing Deviation Reports, Complaints, CAPAs, and Change Control in a Pharmaceutical or GMP industry.
• Detailed knowledge of cGMP, GLP, FDA and Health Canada guidance and Regulations
• Knowledge of Manufacturing and packaging processes is an asset
• Strong research and problem-solving skills, with the ability to effectively perform analysis
• Strong interpersonal skills to facilitate effective interaction with co-workers and other departments.
• Strong written and verbal communication skills are required in order to communicate effectively with key areas/departments.
• Excellent technical report writing skills.
• Ability to work in a fast paced environment and prioritize workload accordingly in conjunction with the Production Management
• Proficiency with applicable software (TrackWise, MES Document Management System, and Microsoft Office)

Working conditions

• General conditions include office and warehouse work; mix of standing, walking, and desk work
• Overtime as required or may need to periodically adjust working hours to meet with shift employees

Physical requirements

Office based

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $73,500 to $92,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and 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.