Specialist, Computer Validation

Taro Pharmaceuticals Inc. - Brampton, ON (il y a 30+ jours)

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Taro is a multinational; science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

Our Brampton location is presently looking for a Specialist, Computer Validation to join our Pharmaceutical Technology Department.

General Summary:
This position plays a leadership role in the implementation of computer systems validation methodology as per the approved company policies and procedures.

Principal Duties and Responsibilities :
Lead Global Computer Validation Activities for systems implemented at multiple Taro sites.
Lead Computer Validation Activities across multiple departments at the site level.
Validation of computer systems including hardware and software to support business systems that have GMP impact.
Write computer validation plans and protocols addressing all critical functions requiring validation.
Review of Validation deliverables including URS, FRS, Migration Plans, Configuration Specification, etc.
Address deviations associated with Computer System Validation for business/GxP impact and resolution.
Write reports to summarize the results computer validation activities.
Recommend corrective measures with the objective of meeting validation requirements when required.
Evaluate system(s) changes using a risk based approach and assign appropriate level of validation requirements.
Ensure compliance is established and maintained at all times.
Write and maintain computer validation related SOPs and/or policies as required.
Maintain electronic and paper computer validation documentation to ensure prompt document retrieval when required.
Effectively manage all assigned computer validation projects.
Train employees on computer validation related activities and SOPs as required.
Keep current with industry and regulatory guidelines.
Flexibility to work overtime when required.
Participate in periodic review of Computer Systems.
Other duties as assigned.

Knowledge, Skills and Abilities

Minimum of a University degree, preferably in a in Computer Science or Engineering discipline.
Minimum five (5) years of experience working in a computer validation capacity within a pharmaceutical-related field or medical devices field combined with a minimum of five (5) years of demonstrated project management experience including project management approaches, tools and phases of the project lifecycle.
Demonstrated knowledge of computer system validation processes using ISPE GAMP5 guideline and or other harmonized international guidelines (PIC/S, ICH) and GMPs.
Experience/Knowledge of supply chain business process is an asset.
Strong knowledge of Health Canada and FDA regulations and GMP.
Ability to establish and maintain trusted and respected relationships with all internal and external stakeholders and influence others to move toward a common vision or goal .
Team player with ability to work collaboratively with others, respects the input and know-how of other team members.
Excellent written and oral communication skills with ability to articulate messages to a variety of audiences
Strong negotiation, and training skills, required to ensure that quality requirements are maintained while also meeting business expectations
Report writing skills.
Strong organizational, multi-tasking, detail oriented, problem solving and root cause identification skills.
Demonstrated understanding of all quality systems (training documentation change control validation vendor management and internal and external audits).
Plans, organizes and monitors time and resources efficiently.

If you are interested in this opportunity, please submit your resume to hr@taro.ca referencing Specialist, Computer Validation in the subject line. We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.

This position is open to applicants legally authorized to work in Canada.

Taro Pharmaceuticals embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

NOTE: All employment is conditional upon the completing and obtaining of a satisfactory background check which may include educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Taro Pharmaceuticals does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Taro Pharmaceuticals explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.