QA GMP & Certifications Specialist
PNP Pharmaceuticals is currently seeking for a QA GMP & Certifications Specialist to join our Quality Control team.
- 9:00am to 5:00pm, Monday to Friday
Principal Duties and Responsibilities:
- Assist the Compliance team in maintaining a growing and integrated Quality Management System that is compliant with GMP requirements from major regulatory bodies such as Health Canada, FDA, and TGA by performing high standard quality oversight on the Quality System to ensure continuous compliance.
- Ensure that PNP is continuously complying with all third-party certifications which include the NSF for Dietary Supplements/ Sports, Informed Choice, Gluten Free, Organic, Kosher, Halal and Non-GMO.
- The Specialist is responsible for the initiation, preparation, review, and evaluation of responses to the customer complaints for all PNP’s manufactured Products and will coordinate all activities for the investigation with internal departments.
- Maintain updated records of all approved documents, Master Documents and logs and ensure that only latest approved documents are used. Ensure completeness and accuracy of documents.
- Provide document control support, including issuance of controlled documents, document tracking, processing, maintain positive and productive interactions with internal departments to resolve issues and ensure procedures are followed from start to end. This includes Change Control Program initiation, tracking and ensure the implementation plans are followed as described.
- Assist in Quality investigations by coordination OOS and Deviation investigations and executing CAPA procedures including facilitating identification of root causes, risk assessment and implementation of corrective actions with monitoring of effectiveness.
- Write Quality SOPs, align procedures with Regulations and company requirements. Support the Compliance team in development and GMP training for all employees involved in the GMP activities.
- Audit internal facilities and systems for compliance to SOPs, cGMP regulations and other applicable regulations. Also participate in audits by external clients and regulatory authorities
- Review & evaluate the Annual Product Quality Reports (APQR) related to Canadian Products.
- Corporate the maintenance of Quality Agreements with clients and contracted services.
- Responsible for vendor qualification & monitoring
Additional Duties and Responsibilities:
- Perform other related duties as needed.
- Participate in planning of department objectives and oversees teamwork efforts to meet goals, project timelines and deliverables.
- Develop and recommend measures and activities which improve productivity, effectiveness, or efficiency of the department
Qualifications and Requirements:
- Hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
- 3 -4 years relevant work experience in pharmaceutical manufacturing industry with minimum 1 year experience as GMP specialist. Highly preferable to be in the manufacturing of solid dosage forms.
Knowledge, Skills and Abilities:
- Knowledge of Good Manufacturing Practices (GMP) for Natural Health Products & FDA Regulations for Dietary Supplements.
- Knowledge of test procedures, knowledge of pharmaceutical equipment operation, lab equipment, manufacturing equipment including, tablet press, capsule filler, bottling line etc.
- Proficient in MS Word and MS Excel.
- Excellent communication (written and verbal) and interpersonal skills.
- Excellent attention to details.
- Good math skills.
- Ability to work and lead a team.
- Ability to multi-task, manage initiatives and handle various task simultaneously.
If you are interested in this position, please apply send us an email at email@example.com with your resume and subject title: “QA GMP & Certifications Specialist”
We thank all applicants in advance for your interest in PNP Pharmaceuticals, but only shortlisted candidates will be contacted for an interview.