Senior Associate Quality Assurance

Designation : Senior Associate

Function : QA

Functional Area : Quality Assurance Contract Manufacturing

Job Role Summary : Manage compliance programs associated with Contract Manufactured products, Assessment of Contract Manufacturing Organizations and 3PL facilities. Routine batch release activities of CMO batches for Canada market 

Job Profile :

• Plan, execute and track the following CMO associated Compliance Programs:
  • Full Batch Review Program
  • Unique Identifier Program
  • Freeze-Thaw Studies
  • Annual Testing Program
  • Transportation Studies
  • Product Launch documentation
• Create Performance metrics of CMOs and provide status reports on the above Programs to the leadership
• Perform compliance assessment of the new CMOs, CDMO, Contract Labs, Contract Packagers and 3PL operations; create an effective preliminary and detailed compliance screening process
• Lead all activities associated with introduction of the new CMO and CDMO, review and approve all associated documentation
• Perform initial GMP and routine on-site and remote audits and checks for all CMO, CDMO, Contract Labs, Contract Packagers and 3PL operations for the products marketed in Canada and USA
• Follow up on the responses from the auditees and ensure CAPAs effectiveness checks execution
• Provide feedback to CMOs concerning documentation management, all quality systems, change control notifications, investigations and laboratory results
• Create, finalize to approval status and maintain periodical review of all Quality Assurance Agreements for CMOs, Contract Labs and Contract Packagers for the products marketed in Canada and USA
• Ensure compliance to responsibilities outlined in executed Quality Agreements
• Ensure Health Canada licensing requirements are met prior to introduction of a new CMOs, Contract Labs and Contract Packagers or a new product
• Assist in site regulatory/ customer inspections
• Respond to customer queries for the CMO products
• Perform investigations with respect to the contract manufactured products, where required
• Perform day-to-day CMO market release activities including review/approval of associated Investigations and Change Controls records. As well as track and monitor the batch release activities
• Support Canadian market recalls for Sun Pharma Canada Inc. products manufactured by CMO and Sun Pharma sites
• Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day.

Job Requirements :

• 5 - 7 years experience in quality assurance/quality compliance experience in the pharmaceutical or related industry environment (creams, gels and ointments)
• Proficient in quality systems such as change control, investigations, documentation, batch review and release.
• Complete knowledge of pharmaceutical operations/standards combined with a strong quality mindset.
• Good organizational skills, detail oriented and multi-tasking ability combined with strong attention to detail
• Excellent written and verbal communication skills with ability to articulate messages and interact with a variety of audiences (internal and external)
• Excellent technical writing skills
• Proven negotiation and training skills in ensuring quality standards are maintained while also meeting business expectations.
• Knowledge of applicable software, example, SAP, Trackwise etc.
• Knowledgeable of pharmaceutical operations
• Knowledgeable of GMP, FDA and HPFBI requirements
• Ability to manage internal and external requirements
• Strong problem-solving skills with ability recommend and implement strategies towards enhancing the quality standards of the department and facility
• Evaluation of customer’s requests without divulging company confidential information
   

Work / Job Experience : 5-7 Years

Type of Experience : QA

Academic Qualifications :

Minimum of B.Sc Chemistry or other associated discipline

Job Post Link : https://tinyurl.com/ysut66jk