About Apotex Inc.
Apotex Inc. is a globally recognized Canadian-based health company dedicated to producing high-quality, affordable medicines. Employing approximately 7,200 people across manufacturing, R&D, and commercial sectors, Apotex operates in over 75 countries. The company is committed to the development of generic, biosimilar, and specialty pharmaceutical products. For more information, visit www.apotex.com.
Job Title: Senior Batch Process Yield (BPY) and Document Review Specialist
Job Summary:
The Senior BPY and Document Review Specialist is responsible for ensuring the accuracy and quality of Batch Process Yield (BPY) reports and related documentation for Signet and Etobicoke sites. The incumbent acts as a technical writer for Change Control processes, oversees the review and submission of Manufacturing Master Records (MMaR), Manufacturing Process Records (MPaR), and Standard Operating Documents (SOD), and drives improvements in documentation systems and processes.
Key Responsibilities:
Batch Process Yield (BPY) Review:
Review BPY reports to ensure data accuracy and appropriate conclusions.
Evaluate e-copies and pre-executed documents for quality compliance.
Escalate critical issues identified during product reviews.
Document Management:
Serve as the Primary Technical Writer for change control processes involving MMaR and MPaR.
Review MMaR/MPaR/SOD drafts for completeness, correctness, and reproducibility.
Maintain tracking systems for SOD processes and ensure timely submissions.
Generate metrics and activity reports for site leaders.
Process Improvement & Training:
Identify opportunities for improvements in drafting, template content/format, and process efficiency.
Develop training materials and programs to enhance the team’s effectiveness in document preparation and submission.
Mentor GSTO technical writers to maintain quality standards.
Leadership & Team Collaboration:
Conduct performance reviews and monthly one-on-one discussions with team members to support their development and achievement of objectives.
Create a trust-based culture that promotes employee growth and aligns with Apotex values: Collaboration, Courage, Perseverance, and Passion.
Attract, hire, and onboard talent, ensuring a seamless transition aligned with company commitments.
Regulatory Compliance:
Adhere to all established safety and regulatory compliance requirements.
Communicate findings and escalate issues as necessary to leadership.
Build and maintain effective relationships with internal and external customers.
General Responsibilities:
Perform tasks in alignment with Apotex’s core values and commitment to high performance.
Execute other duties as assigned by leadership.
Job Requirements:
Education:
Bachelor’s or Master’s degree in Science/Pharmacy.
Knowledge, Skills, and Abilities:
Proficiency in MS Office tools.
Strong verbal and written communication skills.
Experience with online modules and document management systems (added advantage).
Demonstrated leadership and presentation abilities.
Strong interpersonal and teamwork skills.
Adaptability to multitask and meet strict deadlines in a dynamic environment.
Experience:
Minimum 8–9 years of experience in the pharmaceutical industry.
Why Join Apotex?
Global Impact: Contribute to affordable healthcare solutions worldwide.
Inclusive Workplace: Experience a supportive and accessible environment where every employee is valued.
Professional Growth: Engage in challenging projects and opportunities for learning and leadership.
If you’re passionate about quality and innovation, apply now to be part of a global leader in the pharmaceutical industry!
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Delhi | India | New Delhi | PAN-India |Goa :
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Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
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Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Storrs | West Hartford |D.C :
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Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
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Memphis | Nashville |Texas :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Dalian |Republic of China :
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Prague |Republic of Egypt :
Cairo |South Yorkshire :
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Almaty |Remote Korea :
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Warsaw |Remote :
Remote | Remote - Middle East | Remote - Europe | Remote, USA | Switzerland |Bucharest :
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Najran | Khulais | Riyadh | Rabigh | King Abdullah Economic City | Jeddah |Nišava District :
Niš |Singapore :
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Barcelona |Madrid :
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Taipei |Williamson :
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