Regulatory Affairs

Job Responsibilities & Duties:

The main roles and responsibilities of RA/QA Manager include:

• Responsible for ensuring that all finished products released to the market possess the quality required for their intended purpose, meet all external and internal GMP-related standards, and are consistent with the regulatory filings at the time of release and throughout shelf-life.
• Responsible for the final release of products.
• Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality Standards.
• Responsible for the organization and management of an effective Quality Assurance and quality system, covering all Pharmaceutical, Cosmetic, Medical Device and Food products, in accordance with the existing policies and procedures of the company.
• RA/QA Manager reports to the President of RGDI for all quality operating unit decisions to assure independence from the Business Unit. This is also to enhance the quality and compliance performance of the company.
• RA/QA has the responsibility and authority for approving or rejecting drug, cosmetic, medical device and food products manufactured, processed, packed, tested or held for RGDI. Thus, every product that bears the RGDI name should comply with the same quality standards of RGDI.
• Checking of final batch disposition of all finished goods of RGDI. This activity includes reviewing relevant batch documents versus regulatory submissions.
• b. Reviewing and approving all deviations encountered, the adequacy of root cause investigation and recommended CAPAs, as well as monitoring the status of these CAPAs up to closure.
• c. Ensuring that the manufacturer conducts stability testing based on local regulatory requirements. This is done by monitoring the timeliness of the stability testing conducted, as well as reviewing the compliance of stability results against specifications.
• d. Managing changes of all GMP-related activities and systems that may impact the quality and safety of the validated state of RGDI products through the change in standard process.
• e. Managing of all quality related product complaints from intake to closure.
• f. Checking and reviewing the product quality review of all products locally manufactured to verify consistency of the existing process and to identify or develop any product and process improvements.
• g. Implementing Quality Risk Management Plan. RMP is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product life cycle. QRM facilitates and improves decision making based on scientific knowledge with respect of risk to product quality and patient safety.
• h. Managing all technology transfers from RGDI partners, as applicable.
• i. Reviewing all Master files and other relevant GMP documents.
• j. Monitoring the closure of the CAPAs provided for the audit findings conducted with suppliers and suppliers.
• k. Driving the quality culture, build and sustain quality systems at the RGDI and support the management's mandate to implement a robust quality system for GMP activities.

Activities include:

• Ensuring that RGDI complies with Quality Standards. This includes preparation of the local SOPs compliant to applicable PQS.
• Conducting Self Assessments to determine the level of compliance of RGDI to these SOPs and to GMP requirements.
• Conducting focused audits of the suppliers to ensure the continuous compliance of the TPCs.
• Monitoring and reviewing the performance of the suppliers through agreed performance metrics. RA/QA helps in the identification and implementation of improvements, if any.
• Establishing and maintaining prompt notification to management and regulatory agencies following the RGDI process.
• Planning for the scheduled external audits for the year and ensuring that the audit is performed in a timely manner.
• Providing the overall guidance so that the product recall process is done according to regulatory and RGDI requirements.
• Leading the Quality Committee meetings and tracking the closure of the agreed actions.
• Monitoring the various performance metrics of suppliers and reports those metrics falling below target.
• Performing Management Reviews and presenting the result to the Management for actions.

Qualifications:

Graduate of Bachelor's Degree in Pharmacy and a licensed Pharmacist.

At least five (5) year work related experience in regulatory field.

Job Type: Full-time

Benefits:

• Company events
• Employee discount
• Health insurance
• Opportunities for promotion
• Promotion to permanent employee

Work Location: In person