Technical Factory Manager

Job Description

ROLE SUMMARY

• The Technical Factory Manager is responsible to ensure that all technical areas are meeting the SFDA requirements. Moreover, the TFM will be the main point of contact for the site with the SFDA and other regulatory bodies. In addition to the TFM responsibility, this role will supervise the in-process control department in KAEC site.

Responsibilities as TFM:

• Responsible for all technical operations & departments and ensuring that they are performed according to GMP requirements.

• Final approval of raw material & packaging material suppliers, technical agreement in case of use of outsourcing activities, major changes on buildings, production lines & product composition (formula).

• Approve the tasks and responsibilities of the key employees.

• Periodic evaluation of the quality system within the site.

• Approving plans for continuous development.

• Formal liability for recalls, complaints, and coordination with concerned departments to ensure that corrective actions are applied.

• Final approval for any technical documents/records submitted to the SFDA

• Responsible to support the and oversee the controlled substance management process according to the SFDA guidelines

Responsibilities as IPC Supervisor:

• Responsible for effective leadership of team which includes managing the daily operation ensuring that applicable safety guidelines and policies are followed.

• Responsible for counseling colleagues to assure proper development for their success, and to provide corrective action when necessary.

• Manage multiple projects and ongoing work activities within a team.

• Ensure compliance with all government and company regulatory requirements.

• Participate in equipment failure investigations to determine root causes and propose solutions, process operational improvements.

• Assure appropriate communication and implementation of corrective/preventive actions to avoid reoccurrence.

• Prepare and review the procedures and conduct system reviews.

• Inspect Production Lines/areas for cGMP (Current Good Manufacturing Practice) compliance

• Supervise/ Perform in process control testing as established as required.

• Supervise/ Perform IPC test and start up checks as required in accordance with the relevant instructions and standard operating procedures in packaging and manufacturing.

• Ensure all manufacturing processes within section are performed following the appropriate manufacturing and packaging instructions, relevant SOP’s, and controlled documents within their validated parameters to maintain consistent and high product quality.

• Adhere to procedure and instructions so that manufacturing and packaging activities within the section are operated safely, comply with business objectives and local regulatory and Pfizer requirements and EHS standards.

• Develop relevant procedure and equipment alteration if required whenever there are some new products.

• Supervision/ Execution of process optimization /process validation batches.

• Supervise/ Perform manufacturing and packaging activity to the planned schedule to achieve efficiency.

• Verify reconciliation of bulk production and finished good products as per SOPs.

• To provide technical support during technology transfer of project.

• Report to production manager any changes to normal operating process to ensure appropriate actions are being taken, in order to maintain and improve product quality, production efficiency and safety. Raise GMP deviation or any report respectively.

• Check and verify the cleaning activities of manufacturing equipment’s thoroughly so there is no risk of cross contamination.

• Strictly follow the safety guidelines laid by KAEC site. Wear personal protective equipment’s wherever identified.

• Perform the identified equipment’s verification and calibration before its due date and to ensure the equipment’s used is within its calibration due date.

• Develop good relationship with factory staff. This will maximize overall team effort and therefore raise customer satisfaction.

• Maintain good time keeping as per the company policy.

• Maintain good hygiene levels and report any health illness to production manager.

• Handle the incident reporting, change control, batch documents and all other relevant documents.

• Maintain zero defects, zero accident and zero waste.

• Oversees the line clearance activity in thepackaging and manufacturing area.

• Sampling and testing of product during packaging and manufacturing according to approved sampling plans.

• Prepare all the related batch documents SOPs (stander operating procedure), forms and any required documents.

• Carries out required inspection and gives approval for line start up.

• Sampling of blend &/or finished goods for QC (quality control) release testing according to approved SOPs

• Collection of retained samples.

• Complete and maintain quality and production records according to cGMP.

• Inspect & approve the rejects of the in-process materials.

• Participate in all quality activities in production area if required.

• Perform and handle the PQS gap analysis, batch document review, incident reports, change control, CAPA.

• Ensure all production activities are complying with Pfizer Quality standards.

• Ensure training has been completed within the timeline.

• Actively participate in the assessment of the CAS reports, and in the monitoring of the CAPAs that may arise to fill any gap.

• Implementation and follow up the data integrity program in the production department.

• Review the batch record for packaging and manufacturing department.

• Manage and collaborate with production colleagues, to effectively lead and coordinate the investigation process at production department

• Perform data analysis, investigate trends to identify root cause, corrective /preventive actions, and ensure the effectiveness of these actions.

• Coordinate preparation for internal, external and regulatory audits at the level of the production department and monitor the resulting action plans.

• Collaborate with the production team to plan training based on the needs of the department and production colleagues.

• Work in partnership with the site training manager and the production supervisor to assess the effectiveness of the training in meeting the needs of the production department and the development of the production team.

• Monitor, Update and prepare data relating to performance indicators (KPI)in the production department for presentation during visual management meeting.

• Accountability for: ​Manufacturing and packaging operation. Manufacturing and packaging IPC test. Accountable for individually identified risks and escalate to the production manager, where applicable develop risk mitigation plan and monitor the implementation plan. Develop good relationship with factory staff. This will maximize overall team effort and therefore raise customer satisfaction. Co-ordinate with warehouse, Planning, QA, QC and Engineering as and when required. Accountable for individually identified risks and escalate to the production manager, where applicable develop risk mitigation plan and monitor the implementation plan.

• Participating in preparation of SOPs.

Qualifications

Must Have

• The SFDA guidelines mandates that the TFM must have the 3 following requirements: 1) A Saudi National 2) Has a bachelor’s degree in pharmaceutical science 3) Has 3+ years of experience in pharmaceutical operations

• Excellent verbal, written and interpersonal communication skills. English fluency is a pre-requisite

• Strong understanding of GMPs and compliance in the pharma industry.

• Ability to connect and influence people at all levels and develop good working relationships that promote teamwork.

• Computer Skills, PC literate with the following applications: MS Excel, Word.

Nice-to-Have

• Master’s degree

• Leadership experience

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Manufacturing