- Position : Supervisor, Quality Assurance Product Release
- Department : Quality Assurance
- Requisition :19HRCN-012
- Job Type : Full Time
- Posting Date : 02/26/2019
- Location : Brampton, Ontario
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 Supervisor, QA Product Release to join our Quality Assurance Department.
The main responsibility of this position is to establish and maintain a highly-functional QA Product Release group by supervising, leading and mentoring staff. This role is highly visible within the Taro group of companies as accountable to Senior and Executive leadership for product release. This responsibility includes leading the maintenance of a site wide quality program to meet Taro, Canadian and FDA GMP requirements for product release. This position acts as an active influence towards elevating the quality practices and guidelines for product manufactured, packaged or tested at the Taro manufacturing facility.
Principal Duties and Responsibilities :
- Oversee the establishment and maintenance of a highly functional QA Product Release group though leadership and mentoring:
- Providing continuous coaching, feedback and performance reviews,
- Establishing objectives intended for the department’s success and individual career development;
- Facilitating routine departmental meetings
- Oversee the establishment and maintainance of compliant and efficient QA release systems by ensuring timely releases of raw materials, packaging components, bulk, water and finished product releases on a daily basis.
- Maintain and control the tracking systems to plan, coordinate and monitor the site- wide release system.
- Accountable for the maintenance of the ELB and Cognos Reports generated by the ERP system, and uses same for tracking and trending performance against internal release targets as well as formulating projections against the monthly objectives.
- Accountable for QA Release Team training ensuring that all personnel are in good standing with zero overdue training events each month.
- Manage logistics through participation in local and corporate cross-functional meetings on an ongoing basis, as the QA SME, across the organization:
- Is a key contributor at the Production Planning meetings, including Raw Material/Finished Goods release priority meetings, representing QA Release.
- Is a key contributor at Product Launch meetings that drives the QA Release Team’s performance to achieve Day 1 Launch objectives.
- Attend Back-Order meetings, as necessary, as a back-up to the Sr. Manager, where they are authorized to give release commitments of product to the customer.
- Collaborate with other departments such as Materials Management, Quality Investigations, Change Control teams and Operations (Compounding and Packaging) to set priorities and resolve issues proactively that may delay release.
- Identify and implement key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements within QA Product Release.
- Champion business initiatives (e.g. product launches, partnerships with new 3PL partners, expansion of activities/responsibilities of existing 3PL partners—UPS, etc.).
- Key contact with NJDC in order to ensure timely notification of disposition of products.
- Key contact with UPS in order to ensure timely notification of disposition of products.
- Lead coordination with SUN Pharma, Taro and UPS to ensure timely release of inter-site transfer of SUN product to the Canadian market.
- Oversight of the site-wide retention sample program.
- Participate in product recall activities.
- Key QA Release Contact as SME for all internal, customer and regulatory audits.
- Oversight for Issuing packaging work orders and compounding orders to the production floor;
- Implement compliance and efficiency improvements to the release process and revise QA release procedures, as needed;
- Participate in revisions to Compounding and/or Packaging procedures to assess quality impact;
- Lead, and/or participate in the design and delivery of training targeted to ensuring compliance with SOPs & Canadian and FDA GMP compliance requirements for QA, QA Shop Floor, Compounding and Packaging personnel;
- Improve efficiency of QA activities while ensuring compliance with SOPs & Canadian and FDA GMP compliance requirements;
- Initiate, and follow through with actions required to close Change Controls.
- Initiate and participate in non-conformance investigations, including CAPA
- Complete all training assignments and maintain personal training records up to date.
- Back-up for QA Manager, Product Release & Logistics - for QA Release-related activities.
- Participate in Other duties as assigned
Knowledge, Skills and Abilities
- Bachelor’s Degree in Science;
- Minimum 5 Years experience in a Quality role within the pharmaceutical Industry.
- Sound knowledge and application of Health Canada and FDA regulations.
- Demonstrated ability to build, lead and develop a team.
- Ability to multi-task with strong organizational skills to organize daily events to meet departmental and Taro business commitments
- Excellent written communication and report writing skills.
- Strong organizational skills and ability to execute numerous tasks with varied responsibilities demanding attention and detail
- Self-starter with initiative and proactive behaviour.
- Ability to influence others actions while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
- Excellent technical writing, organization, negotiation, time management and interpersonal skills
- Excellent written and verbal communication skills to communicate effectively to key areas/departments (attentive to detail);
- Software skills (Microsoft Word, Excel, PowerPoint, document management systems)
- Experience in coordinating team activities
- Demonstrated efficiency required to effectively support one or more of the following Quality Systems
- Vendor Quality Management
- Documentation System
- Internal Audit Program
- Analyze and resolve unique and complex quality issues that can affect product release (both acute and long-term).
- Analyze and resolve inter-departmental issues affecting processes that will delay product release.
- Liaise with external vendors, manufacturers and also with customers to efficiently resolve challenges surrounding product release.
- Implement strategies and objectives towards enhancing the quality standards of the QA Release process.
If you are interested in this opportunity, please submit your resume to email@example.com referencing <Insert Position Name> 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.
To learn more about Taro Pharmaceuticals Inc., please visit: www.taro.ca.