Associate, Quality Assurance, IT and CSV (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

This role is responsible for assisting Quality Assurance oversight of all aspects of the validation of computerized systems at the facility. Guide business in Validation of computerized system effectively, provide direction, resolve validation issues and ensure proper documentation.  Act as a compliance resource by collaboratively interacting with all departments to create a positive and effective attitude towards computerized system validation and compliance.  This position will entail coordination with other departments within the organization, including R&D.

The role also has oversight of Computerized System Validation (CSV) review and qualification to ensure that those systems are well designed, installed, qualified, and maintained in a state of compliant inspection readiness.

Duties and responsibilities

• Responsible to ensure all aspects of the validation of computerized systems are in compliance with SOPs, CSVMP, FDA 21 CFR Part 11, GAMP, EU Annex 11 and applicable regulatory requirements (including contractors, consultants, and technicians that will participate in computer validation activities);
• Define risk based validation strategies for computerized systems and network infrastructure;
• Assist in QA harmonization of the computer validation approach across the organization;
• Coordinates and guide in the development of validation documents and perform review of:
  • Change controls for computerized system implementations, maintain change control log and follow up with owners on the timely closure of change control files closure;
  • Validation master plans for computerized system implementations;
  • SOPs for computerized system implementations, where required;
  • Risk Assessment and Validation Matrix for new and existing computer systems subject to validation;
  • Qualification scripts, deviations reports or logs. Ensures assignable causes are identified and address corrective actions, as needed; and
  • Vendor approvals for computerized systems including audit review and approvals.
• Support Data Governance Program to establish, control, monitor and record all activities that directly or indirectly impact all aspects of the quality of drug products;
• Develop (with manager’s support), maintain, monitor, and ensure effectiveness of computerized system validation program for GxP computerized systems;
• Participate and present CSV validations in audits;
• Author CSV and applicable Standard Operating Procedures (SOPs). Review, perform gap analysis and provide feedback on corporate guidelines and regulation;
• Act as a compliance resource by collaboratively interacting with cross-functional teams;
• Create a positive and effective attitude towards CSV and regulatory compliance;
• Train staff; ensure training effectiveness;
• Participate and/or leads meetings with IT and business user representatives in order to gain cross functional understanding and consensus on protocol content and protocol execution; and
• Maintains up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and acts as an information resource for the team and wider business.

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 Science, Computer Science or other related discipline;
• Minimum  3-5 years’ experience in a pharmaceutical industry with at least 3 years in Computer system validation (CSV) or Quality oversight for CSV;
• Excellent understanding of 21 CFR Part 11 / Annex 11 and GAMP 5 requirements; Good Working knowledge of FDA and Health Canada Good Manufacturing Practice;
• Experience in inspection from Regulatory agencies officials (Health Canada, USFDA, MOH, MHRA etc.);
• Good written communication and report writing skills;
• Strong influencing skills;
• Strong organizational skills and ability to multi-task; detail oriented;
• Well-developed interpersonal, communication, and teamwork skills;
• Ability to work independently with minimal supervision;
• Hands-on knowledge of Microsoft Office applications and computer systems such as ERP, EBR, QMS and LIMS systems; and
• Ability to resolve problems associated with a wide variety of computer system quality issues that can be more than routine in nature.

Working conditions

Office environment;

Ability to work with aggressive deadlines and changing priorities; and

Numerous and varied responsibilities demanding attention and detail.

Physical requirements

Office based role

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $57,000 to $71,000. 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.