Head of Quality Control
What we are looking for.
Deciem is looking for a driven, results-oriented experienced individual to be the Head of Quality Control to lead and manage the Quality Control Team. This person will manage various projects and oversee the processes for analytical testing of the raw materials, processes, finished product and stability samples.
What you would be doing.
- Leads and manages the QC testing laboratory staff and oversees the processes for analytical testing of raw materials, in-process, finished product and stability samples
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and escalates related issues to Quality Director on timely manner.
- Achieves results through direct reports by communicating job expectations; establishing individual goals in line with departmental objectives, coaching, reviewing performance results; holding accountable; providing cross training opportunities for skill development
- Leads by example and proactively communicates and collaborates with cross functional teams, internal staff, and colleagues to achieve objectives.
- Leads and manages laboratory documentation, chromatography software, and specification sheets for accuracy, completeness, and compliance with established SOPs, specifications, and test methods.
- Technical (Software & functionality) understanding of Analytical instrumentation which include but not limited to HPLC/UPLC (MS) , GC (MS), UV/VIS, FTIR, NIR, KF, ICP MS.
- Approves stability protocols if applicable for scale-up and commercial products.
- Collaborates with the internal departments on a regular basis to gain oversight on the weekly manufacturing production / final release product planning and assists in the creation of the test schedule for the QC team.
- Leads and manages laboratory calibration program and ensue timely completion.
- Compiles data to trend and monitor key department performance metrics and provides reports to Quality Director
- Manages Laboratory Investigation Reports for any applicable nonconformances. Works with other departments and leads QC investigations to ensure accuracy and completeness of out-of-specifications, out-of-trends, deviations, and non-conformances
- Oversees the training and qualification of laboratory staff on newly written or revised methods and procedures
- Ensure compliance to the regulatory and the company’s data integrity requirements.
- Acts as the primary point of contact for laboratory investigations information with internal and external auditors and regulatory inspectors.
- Leads in the implementation of LIMS, continuous quality improvements, CAPEX projects and lean laboratory initiatives in accordance with GLP
- Develops, reviews and revises laboratory documentation as required. Initiates change control documents as required
- Ensure safety, health and environmental procedures are given due priority. Identify, investigate, correct and document potential environmental and safety problems
- Other duties as assigned
What skills and qualifications do you need?
- Expertise with cGMP manufacturing knowledge, and ISO / Health Canada/FDA/EMA regulatory requirements for cosmetic, NHP & OTC products.
- Demonstrated experience with creating and implementing effective Laboratory Information Management System (LIMS) , inclusive of writing SOPs and QC record review; facilitating and closing investigations, deviations and associated CAPA’s
- In depth understanding and application of industry standards and cGMP/GLP guidelines.
- Experience in implementation of LIMS
- Professional certification as Certified Quality Manager will be an asset
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Proven ability to lead subordinate staff and work with senior level leaders
- The desire and ability to work in a fast-paced environment
- Strong collaboration, teamwork, organizational skills with attention to details
- Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders.
- Advanced knowledge of MS Office application (Word, Excel, Power Point etc.), ERP System (Dynamic 365, SAP etc.), Google Applications (Gmail, Drobox etc.), Project Management tools (Wrike etc.), Visio and Adobe Acrobat Software
- 4+ years of people management and/or leadership experience is required
- Relevant education in Science OR equivalent work experience is an asset
Kindly send us your resume to email@example.com. We really appreciate your effort in applying for this position. However, only those candidates who have been shortlisted for interviews will be contacted. By emailing us your resume you agree to accept the Job Applicant Policy.
And the serious stuff:
DECIEM is an equal opportunity employer. We prohibit discrimination based on age, color, disability, national origin, race, religion, sex, sexual orientation, and any other legally protected class in accordance with applicable federal, provincial and local laws. We are also committed to creating and maintaining an inclusive and accessible workplace. If you are contacted for an interview and require accommodation during the interviewing process, please let us know.