Quality Document Reviewer

3 weeks ago

Toronto, Canada Apollo Health And Beauty Care Full time

Apollo Health & Beauty Care (Apollo) is a premium developer of private label and control label health & beauty care products and leverages unique expertise and experience in developing national brand-equivalent products designed to compete equivalently with the most popular national brands. The largest private label and control label personal care manufacturer in Canada, Apollo has formidable penetration and distribution in the North American marketplace and also services customers throughout Central and South Asia, Mexico, Europe and Asia. Building on our core values of Excellence and Commitment, Apollo has established itself as a market leader that attracts the industry's top talent. We are currently searching for an energetic, motivated _
**_Document Reviewer _**:

- to join our Team_

**POSITION SCOPE**:Document Reviewer audits ALL documents in use in production to maintain, identify and correct any non-conformances with respect to compliance of Good Documentation Practices as outlined in cGMP (current Good Manufacturing Practices).

**RESPONSIBILITIES & DUTIES**:

- Audit on-line documentation practices to ensure GDP requirements are met & completed
- Review of production batch records for completeness and accuracy
- Interact with production personnel in educating them on correction, addition and completion of such records per applicable GMPs
- Provide guidance including on-line training to maintain process control when required.
- Review Statistical Process Control Charts (SPC), production Fill Sheets, Batch Sheets etc. ensuring complete Batch Record review - assuring that there are no errors; if errors or omissions have occurred, that they have been corrected appropriately.
- Ensure that all documentation meets cGMP Compliance.
- Issue and assign process of corrective action for rework.
- Generate reports as required, including statistical analysis based on documentation.
- Create and maintain an orderly filing system including hard copy and electronic databases for batch records, CofA’s, etc.
- Adhere to all QA/QC and Company policies and procedures including health and safety.
- Follow all procedures and wear personal protective equipment as outlined in the health and safety manual.
- Identify and report any hazard(s), accidents, and injuries requiring first aid, health care, lost-time injuries, occupational diseases or incidents in the workplace.
- Use equipment, materials and machinery only as authorized.
- Any other related duties as required

**JOB SPECIFICATIONS**:
**KNOWLEDGE/EDUCATION/EXPERIENCE**: 2-3 years’ experience with high school diploma or equivalency required or 1-2 years’ experience with post-secondary education or other job required certification or license required; previous experience in a cGMP environment is an asset; Knowledge of computers an asset; Knowledgeable in understanding and performing audits for Good Documentation Practices

**INTERPERSONAL SKILLS/CONTACTS**: some access to confidential or sensitive information; some internal interactions and/or some minor external interactions; purpose of internal/external contacts is not related to complex matters; no selling, negotiating, consulting, teaching/instructing, or advising; standard level of written and verbal communication skills required for successful job performance

**PROBLEM SOLVING/JUDGMENT**: position is closely monitored and decisions follow prescribed guidelines; some minor analysis required; occasionally makes recommendations or referrals; responsible for solving simple technical problems

**MENTAL EFFORT**: requires average levels of concentration and/or attentiveness; average duration and/or intensity of efforts; requires average amounts of thinking, watching, listening, verifying, checking numbers, creating or designing

**PHYSICAL EFFORT**: occasional duration or intensity of physical effort; moderate energy required in terms of standing, walking, lifting, keyboarding, pushing, pulling, sitting, packing, assembling, bending or twisting; includes moderate fine or coarse movements

**MATERIAL RESOURCES**: average level of consequence and costs associated with errors as related to losses of time, money, or property; moderate responsibility for machinery, work aids, equipment, materials, properties, products, stock, inventory or tools

**INFORMATION RESOURCES**: average level of consequence and costs associated with errors as related to losses of time, money or property; average responsibility for information and or services; limited access to confidential, sensitive or proprietary information

**PEOPLE/POLICIES/PRACTICES**: no responsibility for people, policies or practices in terms of assigning work, development, evaluation, supervision, health and safety, performance, scheduling of work, training, coaching, or well-being; may occasionally demonstrate work practices to others

**FINANCIAL RESOURCES**: no responsibility for financial data, money or financial transactions, financial records, expenditu

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