Job Description

Duties and Responsibilities:

• Coordinate and performs batch record disposition of development, finished products and raw materials
• Review deviations, CAPA's, change controls, and any other site/product related documents adequate levels of documentation are adequate and compliant to existing procedures
• Drive continuous improvement and enhancement efforts to the disposition process to ensure an efficient yet compliant process is maintained
• Support regulatory agency inspections, by way of auditing, training and preparation, and tracking commitments
• Support maintenance of central file correctives and inspection history
• Write and review policies, Standard Operating Procedures (SOPs) and associated processes/guidelines
• Provide support to the investigation process and follow-up to assure timely discrepancy closure
• Participate in the internal audit program
• Assist in revision of SOP's for all departments
• Ensure strict adherence to Standard Operating Procedures and GMP principles
• Ensure GMP compliant start-up
• Act as backup person for the inspectors by checking in-process testing done by production technicians by performing tests, reviewing test data, filling in the manufacturing and packaging batch records and writing investigations according to SOPs and GMPs.

Requirements:

• Bachelor's degree in Pharmacy or Pharmacology. Post graduate vis-a-vis qualifications is desired (e.g. cGMP, MBA, etc).
• Previous experience in Pharmaceutical Manufacturing and QA role is desired
• Exposure and hands-on different roles at different manufacturing disciplines (e.g. Production Inspector, Quality Control, Engineering) is definite plus.

Job Type: Full-timeSalary: Php15,000.00 - Php18,000.00 per monthBenefits:

• Additional leave
• Company Christmas gift
• Company events
• Discounted lunch
• Employee discount
• Free parking
• Health insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• 13th month salary
• Overtime pay
• Performance bonus

Ability to commute/relocate:

• Quezon City: Reliably commute or planning to relocate before starting work (Required)