شركة صلالة لصناعة المستلزمات الطبية – وظائف شاغرة

أعلنت شركة صلالة لصناعة المستلزمات الطبية عن توفر شواغر وظيفية لديها بمسمى :

1. Project Manager

Key Responsibilities
• Lead the planning and implementation of project.
• Develop full scale project plans.
• Design and execute the project work plans and revise it appropriately to meet changing needs and requirements.
• Manage project budget.
• Track project deliverables using appropriate tools.
• Provide direction and support to project team.
• Reviews contracts for constructions and engineering.
• Negotiating and administration of purchasing contracts.
• Stock and materials management.
• Proactively monitors the project to ensure

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2. Quality Assurance Manager

Knowledge/Skill
• BS in Science (Chemistry, Pharmacy, Microbiology, Biology, Engineering, or a related pharmaceutical science).
• Eight (8) years of progressive managerial experience within the Quality Assurance, Quality Compliance and Quality Control function in a pharmaceutical/health care industry, with at least five (5) years of experience in one of the following areas: Quality Control laboratory, Aseptic Techniques, Oral Solid Dosage and other forms.
• Ability to develop and apply the company’s operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas.
• Proficient in cGMP’s and FDA / EMA regulations and requirements.
• In depth scientific knowledge related to analytical and chemical science.
• Knowledge in analytical instrumentation
• Excellent analytical and problem-solving skills
• Experience in containment technologies.
• Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important for evaluating the potential impact of product decisions.
• Excellent verbal, written and presentation skills.
• Must be innovative and creative and utilize all available resources.
• Working knowledge in PC’s and electronic tools.
• Excellent communication skills in English language is a must.
Key Responsibilities
• Ensures Quality Assurance and Quality Control functions (Incoming Laboratory) are aligned to support the site business units.
• Maintain high standards of quality at the department through managing and continuously improving the effectiveness of the department processes and systems.
• Reviews and approves product / processes related documentation such as: Validations, SOP’s, etc.
• Provides quality support to the business units to optimize compliance and efficiency.
• Assures the resolution of products and process issues associated to Quality Events and that existing laboratory methodology at the site is healthy and the validation is maintained within the company’s and international guidelines.
• Establishes a system for disposition of raw materials, API’s, packaging, and labeling materials to ensure an effective process /system for disposition of raw materials, API’s, packaging, and labeling materials.
• Approves or rejects specifications impacting raw material and packaging components.
• Provides guidance to the site Change Control activities to assure they are following all regulatory requirements.
• Supports the QC/QA efforts during the transference and validations of the Dosage forms and parenteral incoming materials at the site.
• Supports the site audit readiness activities related to all Dosage forms and incoming materials at the site.
• Approves product risk management plan and process.
• Supports the Annual Product Review approval process for all dosage forms and recommends next steps and/or corrective actions based on trends.
• Ensures that Corporate Guidelines/Policies are established within the Technical Operations Corporate framework and are effectively implemented and monitored and assures that the manufacturing and packaging procedures are properly followed and adequate for their use.
• Writes, reviews, and implements departmental procedures to update them with current practices and Regulatory requirements.
• Approves the Certificate of Analysis (COAs) and Certificate of Compliance (COC) for products, according to market requirements.
• Coordinates priorities to assure timely product releases for different markets.
• Assures an appropriate lot disposition for all incoming materials.
• Supports departmental budget preparation activities.
• Promotes and model the company’s Core Behaviors, facilitating teamwork, providing coaching, feedback etc.
• Supports all site Initiatives in addition to the product transfer initiatives and any other assignments based on business needs.
• Ensures there are effective systems for the maintenance and calibration critical equipment.
• Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and incoming laboratory, and Annual Product Quality Review (APQR’s) elements.
• Reviews supporting data for compliance with cGMP documentation practices.
• Verifies compliance with the company’s Policies and Guidelines.
• Participates as quality representative or liaison in the site project.
• Supports Process/Manufacturing decisions during audits with regulatory agencies.
• Performs pre-operational review form approval in the manufacturing and incoming area.
• Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.
• Verifies consistency with other site procedures and/or specifications.
• Reviews and approves investigations related to products dosage forms and incoming materials.
• Review and approves deviations, Corrective and Preventive actions (CAPA’s), prepares CAPA Effectiveness report, Change Controls and other Quality System documentation.
• Evaluates and approve critical area drawings.
• Approves or reject specifications impacting drug products, raw material, or packaging components.
• Ensures the designation and monitoring of storage conditions for quarantine materials and products.
• Ensures that an effective system for returns and rescues that include assessment, investigation and disposition is in place.
• Prepares site Key Performance and trending metrics.
• Participates in the Material Review Board.
• Evaluate Standards and Regulations SOPs to identify and eliminate gaps in policies.

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