Line Inspector, Quality Assurance

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 main responsibility of this position is to perform regular QA inspection checks during the day to day packaging and compounding operations at Sun Pharma Canada Inc. This activity would include routine line inspections for GMP requirements, bulk and documentation to ensure first time quality is built into the finished product to meet SPCI and government agency cGMP requirements.

Duties and responsibilities

• Perform routine line clearances/inspections on the packaging lines.
• Provide Line Clearance certification and re-certification to production floor
• Ensure routine compliance of day to day activities on the compounding and packaging areas; working with operations personnel to achieve compliance.
• Monitor packaging and compounding to ensure that batch documentation requirements and SOPs are being followed.
• Review the required paperwork for accuracy and compliance on line and upon completion of the activity.
• Initiate incident reports and perform initial floor investigations and impact assessments to ascertain product quality impact as required.
• Coordinate and cooperate with investigation team to complete investigations in timely manner.
• Collect representative samples for testing and retention, and ensure all relevant paperwork is complete. Submit samples/re-samples to laboratory in a timely fashion to meet business needs.
• Maintain sample and retention records program.
• Communicating discrepancies to QA Manager or other departments where required.
• Work effectively with operation personnel to build in quality up front in the process.
• Prepare and update written procedures (SOPs/Forms/WIs) in areas of responsibility.
• Automate job functions to achieve continuous increase in productivity.
• Issuance, monitoring, review and archival of Production Logbook review,
• Perform Real time review of PWOs and related documents (paper documents as well as /electronically)
• Review MFs (paper / MES), release bulk to packaging, enter and verify CPPs data as applicable
• Perform QA review for Magnehelic gauges, Pest control and Temperature monitoring in the GMP areas and prepare quarterly EM reports
• Perform routine inspection of GMP areas and provide coaching to improve compliance and GMP behavior
• Provide continuous support to packaging line, assess issues in GMP manner and provide real time solutions
• Initiate change control as required
• Initiate incident reports related to production areas, as required
• Provide floor support to investigation team and perform QA review of event reports, as required
• Oversee temperature monitoring systems for GMP areas; TempTale procurement, configuration, installation and monthly data downloading and trending.
• Initiate Product Hold / Reject notification requests
• Record GMP observations on production floors on shift basis and communicate as required
• Update databases as required related to Quality Operations i.e. MF tracker, correction tracker for RFT, line clearance certification / decertification tracker etc..
• Review and approve exceptions in electronic batch system.
• Provide one on one coaching to packaging support staff i.e. mechanics to improve RFT and good documentation practices
• Share GMP ideas/ thoughts and provide feedback to production floor during kick off meeting/weekly/monthly meetings
• Other duties and projects as assigned

Knowledge, Skills and Abilities:

• Thorough GMP and SOP knowledge
• Knowledge of pharmaceutical manufacturing processes and chemicals
• Excellent written and verbal communication skills to communicate effectively to key areas/departments
• Ability to multi-task with strong organizational skills to organize daily events to meet departmental and Taro business commitments
• Ability to work in a fast-paced environment and prioritize work accordingly.
• Strong interpersonal skills to interact with production line staff and management staff
• Training in WHMIS
• Strong computer skills are an asset

Problem Solving:

• Any deviations to procedures or systems are brought to the manager’s attention with logic, data and possible corrective measures
• Analyze situations and make decisions that may impact on production efficiencies and quality requirements
• Effectively communicate deviations and corrective actions to manager to establish continuous improvement practices

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

• Requires Bachelor’s Degree in Science, or equivalent
• Minimum 1-3 years QA/QC experience in pharmaceutical industry, preferred QA experience within the production/manufacturing environments

Working conditions

• Clean environment with occasional exposure to higher than normal noise levels.
• Regular exposure to moving equipment
• Exposure to wide variety of bulk products, raw materials and chemicals on a daily basis.
• Continuous walking and standing with lifting involved
• Occasional overtime and vacation coverage

Physical requirements

On floor / Office based – Rotational Shift

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $62,000 to $77,500. 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.