QA Documentation Specialist
1 week ago
Atarah Pharmaceuticals is a pharmaceutical manufacturer, specialising in the production of high-quality customised products such as skin care, nutriti..
Atarah Pharmaceuticals is a pharmaceutical manufacturer, specialising in the production of high-quality customised products such as skin care, nutritional supplements and medical devices. With a focus on innovation, quality, and customer satisfaction, we have established ourselves as a trusted partner for businesses seeking premium cosmetic manufacturing solutions.
Position Responsibilities
- Ensure compliance with applicable SOPs and production requirements.
- Understand and oversee supplier connections with follow-up actions.
- Review supplier documentation for compliance to relevant safety and quality expectations.
- Attends regular department meetings as required or assigned.
- Routinely recognizes and resolves Quality Issues on manufacturing floor.
- Seeks management guidance on complex issues.
- Complete annual supplier verification checklists, confirming expectations have been met and the appropriate Procurement representative is notified with results.
- Review overall performance of each supplier and maintain statistics for each supplier and report the high and low performers to the Senior Management.
- Update the Raw Material Hazard Analysis and COA requirements according to the level of risk.
- Observe and evaluate processes to make decisions on issues relating to quality program adherence and improvement.
- Review new ingredient specifications for compliance against supplier information.
- Ability to work independently with little to no supervision and as a member of the team.
- Assist in developing SOP ’s policies, W.I. policies and programs and production paperwork.
- Manage the Document Control System and maintain all documents to include tracking managing document processes and tracking of procedure training.
- Assist in Training, either onsite or offsite, as directed by the Managing Director.
- Update and create product specifications for all products such as work in progress and finished goods.
- Must be able to review documentation and ensure it is documented appropriately and adequately.
- Handle customer requests such as documentation, samples, etc.
- Perform internal facility audits such as Good Manufacturing Practices (GMP) etc. Individual must be able to track non-conformities and their respective corrective actions.
- Assist in stock receivables and inventory management.
- Assist in external audits and coordinate any follow-up actions required.
- Must adhere to the GMP’s and all other quality programs.
- Wear PPE when required and strictly adhere to all safety procedures.
- Responsible for ensuring work area is clean and organized.
- Serve as a point-person to proactively search out QA solutions internally and externally.
- Perform other duties as assigned.
Qualifications:
- ITE/Diploma/Degree or other related science discipline
- 1 year working experience is preferred
- Knowledge of GMP standard and manufacturing is a plus.
- Good Oral and Written communication skills in English
- Good interpersonal communication skills, good organizational skills
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