Manager, Quality Assurance Scientist - Manatí, Puerto Rico - Weil Group, Inc

Descripción

PRINCIPAL OBJECTIVE OF POSITION

Accountable for assuring that the manufacturing and/or support areas operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) are performed in compliance with domestic and international cGMP regulations, and Client policies and procedures and for providing scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, forms, protocols, procedures, qualification, and validation reports.

Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed.

Comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

MAJOR DUTIES AND RESPONSIBILITIES:
State the most important activities and accountabilities of this position, the achievement of company or business goals. (Attach additional sheets if needed)

• Interfaces directly with manufacturing and/or support areas operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.
• Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging and relevant activities in the operations areas.
• Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
• Provides key technical guidance and oversight to manufacturing and/or support areas operations areas (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others to assure the appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
• Ensures compliance of all procedures (SOP's) to avoid potential regulatory and compliance issues; including GDP and electronic systems compliance.
• Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.
• Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities and utilities providing coaching from Quality perspective.
• Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
• Supports risk analysis process when required per procedures.
• Evaluates product impact and provide lot disposition recommendation when an investigation is completed as needed.
• Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner.
• Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
• Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings, as required.
• Evaluates documentation compliance, including data GDP compliance and electronic system data compliance, and its overall management requirements for all manufacturing and support areas, including QC laboratories, such as CR's, SOP's, BR's, Forms, Logbooks, BOM's, WPP's, qualification and validation Protocols, according with government regulations and Client Policies.
• Provides support to the area QA Leader during the budget preparation activities.
• Evaluates department performance indicators and develop the appropriate corrective actions if needed
• Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).
• Develops sampling plans based on acceptance quality level criteria when additional or special testing is

required.

• Performs trend analysis to provide recommendations in order to improve the process and /or the

product quality.

• Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established.
• Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
• Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings.
• Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
• 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 microbiology laboratory, and Annual Product Quality Review (APQR's) elements.
• Approves or reject procedures impacting drug products, raw material or packaging components.
• Verifies compliance with Client Policies and Guidelines.
• Participates as quality representative or liaison in site projects
• Performs pre-operational review form approval in the manufacturing and packaging 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 process, products, utilities, microbiology laboratory and calibrations.
• Approves Corrective and Preventive actions (CAPA's).
• Approves or reject specifications impacting drug products, raw material or packaging components.
• Ensures there are effective systems for the maintenance and calibration of equipments and approves of calibration requests.
• Ensures the designation and monitoring of storage conditions for quarantine materials and products.
• Reviews and approves procedures related to process, products, utilities, and laboratories.
• Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials

DECISION MAKING
A. Describe the position's responsibility for taking action, making final decisions and developing recommendations.

Limiting factors might include existing policies, procedures, laws, regulations, internal controls, etc:

• Incumbent has to make firm decisions and recommendations regarding implementation of government regulations and corporate policies to achieve full compliance of the operational areas.
• Incumbent has to take actions as deemed necessary and/or to communicate management in a prompt manner. Inappropriate decision or action regarding a situation may result in a business and quality impact.
• Sense of urgency and analytical thinking are critical competencies required for this position.
• Undue delays in tasks execution may result in business and quality impact.
• Incumbent has to meet with the necessary areas to assure prompt solution of quality issues.

B.

Describe the nature of supervision received, the degree to which procedures, methods and goals are outlined by the supervisor, and the immediacy of supervision:

• The incumbent will be capable to work with minimum supervision.
• On emergency situations, the incumbent may be required to make immediate decisions on the course of action of a lot without direct consultation.
• Notify immediate supervisor of any inconsistencies or violations to Company operation procedures and policies.

CONTACTS Describe the most important working relationships of this position.

Include the frequency, level, and the purpose of contacts necessary for effective performance:

The incumbent will have interaction with personnel at all levels.

• Daily contact with Planning Department, QC Laboratories, Warehouse, Technical Services, Validation, Information Management, Packaging and Manufacturing departments of the site.
• Management and Corporate Quality Unit is required.
• Could interact with governmental regulatory agencies, such as FDA, DEA, MCA, etc.

KNOWLEDGE / SKILL Describe the type and extent to which knowledge of a specific type is required to perform this job in a satisfactory manner.

Where skills can be obtained through formal training / education and experience, list the type and amount of education and experience that would typically prepare an individual for this position:

• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy).
• Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing
• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and team work oriented
• Technical and scientific capability to make firm decisions and recommendations
• Excellent interpersonal skills and the ability to interact with people at all levels
• Effective communication Skills
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed

The following pre-requirement only applies to current personnel, and candidates applying, to a position assigned in the Inspection and Packaging areas:

• Approve the sight screening test established within the Quality Assurance or Packaging Standard Operating Procedure (SOP).

WORKING CONDITIONS Describe the extent to which the job must be performed under working conditions that are considered undesirable, potentially hazardous, require travel, or require absence from home overnight:
A.

Describe exposure to any hazards / disagreeable conditions in the work environment:

• Minimum exposure to hazardous areas
• Minimum personal protective equipment (safety shoes, safety glasses, hard hat) required.
• Possibility of minimal or minor exposure due to visit to manufacturing/exposure areas; or on emergency

situations.

• Special gowning as defined and required in the Manufacturing and other required areas
• Constant concentration and visual effort to perform Acceptance Quality Level in the product inspection area.

B.

Travel required (describe nature and frequency):

• No significant travel required. Less than 15% of the normal work time.

C.

Overnight absences required (per typical month):

• No significant absences from home per month not due to shift work.

D. Shift

• Work irregular hours, rotative shifts, weekends and holidays when needed.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*