Stelis Biopharma Quality Assurance Job For MSc & MTech Life Sciences

Stelis Biopharma QA Job For MSc & MTech Life Sciences

Stelis Biopharma is a leading, fully integrated biopharmaceutical contract development and manufacturing organization. The powerhouse to progress your biologic products to market as efficiently as possible, we can cater for the entire product lifecycle for our customers for both drug substances and drug products.

Name of Post – Senior Manager-Quality Assurance

Location – Bengaluru, Karnataka, India On-site

About the job

1: Strategic:

1. Ensure Quality and Compliance across all activities associated with Biolexis
2. Evaluate, implement and monitor Quality systems at both Drug substance & Drug product Manufacturing and Quality Testing sites, and ensure compliance with respect to documentation control, Training, and Quality Management systems.
3. Audit the Drug substance (DS) and Drug Product (DP) Manufacturing and Quality Testing sites routinely and ensure All time audit readiness is maintained for regulatory inspections.
4. Evaluate and ensure a culture of data integrity is maintained at the manufacturing site(s) & Quality Control labs, in line with ALCOA++ principles.
5. Evaluate and ensure 100% compliance at Manufacturing Sites & Quality Control labs (Biological, Chemical, and Microbiology)
6. Co-develop, co-evaluate, and co-establish program-specific stability testing strategy(-ies) for the therapeutic products along with the regulatory team and development partners.

2: Operational:

1. Collaborate with the partners (inc. CDMOs and CROs) and cross-functional teams (internal and external), to enhance and improve Quality systems and procedures.
2. Ensure Standard operating procedures, policies, protocols, and quality reports are aligned with cGMP regulations and best industry practices.
3. Coordinate Training/Knowledge sharing discussions on cGMPs, GDP, etc., and ensure the training records are up to date.
4. Responsible for ensuring Quality Management Review meetings are conducted periodically and effectively.

3: Quality Management System:

1. Ensuring all QMS elements like Change Control (CC), Deviation, Investigation, and CAPA are initiated and closed as per the timelines. Ensure the overdue QMS elements are closed with adequate justification in coordination with the Quality services department.
2. Responsible for ensuring the investigations are appropriately closed out with effective CAPAs in place. Also responsible for following up on CAPA effectiveness, as required.
3. Ensure that Out of Specification / Out of Trend results are promptly reported, thoroughly investigated, and appropriately closed in the Quality Management System.
4. Ensure that all GMP activities (manufacturing, testing, validation, stability, etc.) are conducted in accordance with the prevailing SOPs and protocols.
5. Ensure that Market/customer complaints and product recalls (if any) are handled and addressed as per the approved SOP.
6. Responsible for qualifying vendors for sourcing Raw materials and packaging materials used for GMP activities.
7. Responsible for ensuring 21 CFR Part 11 compliance of all equipment/instrumentation used for GMP activities. Also, responsible for ensuring all such equipment & instrumentation are qualified/validated and are maintained and calibrated routinely as per established procedures.
8. Responsible for approval/verification of SOPs, Work Instructions, Protocols, Summary reports, Study reports, Qualification/validation reports, Investigations, Deviations, Change Controls, etc.
9. Responsible to ensure the retention samples are collected and maintained as per the requirements specified in the approved procedure.

4: Audits, Compliance, and Risk Management:

1. Ensure establishment and maintenance of cGMP compliance at manufacturing and quality testing sites through periodic audits.
2. Ensure internal audits are periodically conducted and systems are improved based on risks identified.
3. Assess the regulatory landscape to understand compliance trends and identify and deploy risk mitigation strategies.
4. Act as the primary point of contact on all Quality-related matters, both internally and externally.
5. Ensure all-time readiness of sites for various regulatory & customer audits.
6. Assure compliance with International regulations towards contributions to regulatory submissions.
7. Ensure that the supplier and subcontractor audits are regularly conducted and reported as scheduled.
8. Maintain an awareness of new and proposed legislations that impact the business and communicate to and advise the Senior Management Team.

5: Finance:

1. Responsible for proposing CAPEX pertaining to the QA department.
2. To comply with the budget requirements as agreed.

6: People:

1. Develop a Quality culture within the team and across the organization.
2. Mentor and provide leadership support and quality-focused guidance to the teams (internal and external).
3. Enable QA support to cross-functional teams to meet project deliverables.

Education:

• MSc or MTech (Life sciences or related discipline).

Relevant Experience:

• Experience in CMC functions is strongly preferred.
• Experience in facing regulatory audits strongly preferred esp. by US FDA, EMA, etc. (highly regulated markets).

Business Understanding:

• In-depth understanding of Biologics product development and Product Lifecycle Management.

Knowledge:

• Strong understanding of current GCP, GLP, and GMP regulations.
• In-depth understanding of at least one area: Development, Production, Clinical, Commercial.

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